FDA Calendar

Guardant Health, Inc presented data today from a study showing that its methylation-based Shield™ multi-cancer detection (MCD) test demonstrated high specificity and clinically meaningful sensitivity across ten tumor types,* while also providing information to guide clinical diagnostic evaluation.

Erasca, Inc. today presented new preclinical data reinforcing the best-in-class profiles of Erasca's RAS-targeting franchise at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.

Abivax SA announced the completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis.

Xencor, Inc announced positive interim results from its first-in-human study of XmAb942, a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD).

Innate Pharma SA today shared new preclinical data for IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4.

Nuvalent, Inc. announced the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, which supports the rational molecular design of zidesamtinib, its novel and selective ROS1 inhibitor.

Nuvectis Pharma, Inc. today provided poster presentation highlights for NXP900 from the 2025 American Association for Cancer Research Meeting (2025 AACR).

Moleculin Biotech, Inc., announced that an abstract and poster presentation regarding the Company's next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, on April 28, 2025, at the McCormick Place Convention Center in Chicago, IL.

Cingulate Inc announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301.

RenovoRx, Inc announced that Johns Hopkins Medicine is now initiated to enroll patients with locally advanced pancreatic cancer (LAPC) in RenovoRx's ongoing Phase III TIGeR-PaC clinical trial.

Northstrive Biiary of PMGC Hosciences Inc. ("Northstrive"), a subsidoldings Inc. announced the filing of four novel patent applications for its two candidates EL-22 and EL-32.

LifeMD, Inc announced plans to offer broad, affordable, and streamlined access to Wegovy® (semaglutide) through NovoCare® Pharmacy.

aTyr Pharma, Inc. announced that the Company will present a poster featuring preclinical data for ATYR2810, a monoclonal antibody targeting neuropilin-2 (NRP2), at the American Association for Cancer Research (AACR) Annual Meeting 2025, which is being held April 25 – 30, 2025, in Chicago, IL.

ZyVersa Therapeutics, Inc. announces newly published data supporting the potential of its Inflammasome ASC Inhibitor IC 100 to slow the progression of Parkinson's disease.

Profound Medical Corp. announce initial perioperative data from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy ("RP") in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.

Palatin Technologies Announced Updated Results From Responder Analyses Of Its Pivotal Phase 3 MELODY-1 Trial Evaluating The Safety And Efficacy Of Pl9643 Versus Placebo For Dry Eye Disease

- Genprex, Inc. announced that its research collaborators have been selected to present at the upcoming American Society of Gene and Cell Therapy's (ASGCT) 28th Annual Meeting being held May 13-17, 2025 in New Orleans, Louisiana.

AbbVie announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).1

Bicycle Therapeutics plc announced the presentation of additional human imaging data that validate the potential of MT1-MMP, a tumor antigen overexpressed in many cancers, as a novel target for cancer treatment and demonstrate the positive properties of Bicycle® Radioconjugates (BRC®) for radiopharmaceutical imaging.

Pasithea Therapeutics Corp announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004.

Cullinan Therapeutics, announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S.

Perspective Therapeutics, Inc. announced today that the first patient was treated with [212Pb]PSV359 in a Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α).

Seres Therapeutics, announced that it will present three related posters at the upcoming 2025 Digestive Disease Week (DDW) Conference being held May 3-6, 2025, in San Diego, CA.

Exact Sciences Corp announced the company will present 15 abstracts during Digestive Disease Week (DDW) 2025, taking place May 3-6, 2025, in San Diego, California.

NanoViricides, Inc. provides further details on its Measles drug development program herewith.

BrainStorm Cell Therapeutics Inc. announced the acceptance of new pharmacogenomic data for oral presentation of new findings on NurOwn® at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting, to take place from May 6 - 10, 2025 in New Orleans.

Compass Pathways plc announced it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization.

Abeona Therapeutics Inc. announced the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN™ (pronounced as ‘ZEE-vah-skin') (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease.

Monogram Technologies announced it has obtained regulatory approval from India's Central Drugs Standard Control Organization ("CDSCO") to import its mBôs TKA system to conduct a 102-patient, multi-center clinical investigation evaluating the safety and effectiveness of the Monogram TKA System.

CSL Vifor and Travere Therapeutics, Inc. announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

Coherus BioSciences, Inc announced data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization.

Relmada Therapeutics, announced that positive initial data from the Phase 2 study of NDV-01 showed that 90% of patients achieved high-grade disease-free status at any time point following treatment, demonstrating strong clinical activity and supporting further development of NDV-01 for the treatment of non-muscle invasive bladder cancer (NMIBC).

Puma Biotechnology, Inc. announced that clinical data on neratinib were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025.

Agenus Inc announced that data from the investigator sponsored NEOASIS study were presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.

Foghorn® Therapeutics announced new preclinical data for potential first-in-class medicines, including FHD-909, a SMARCA2 (BRM) selective inhibitor, and the Selective CBP degrader program at the 2025 American Association for Cancer Research (AACR) Annual Meeting.

ORIC Pharmaceuticals, Inc. announced the presentation of a poster at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting preclinical data on ORIC-944, a potent, highly selective, orally bioavailable allosteric inhibitor of PRC2, which demonstrated synergistic activity and improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in models of prostate cancer.

Adicet Bio, Inc announced the acceptance of an abstract for an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting taking place May 13-17, 2025, in New Orleans, LA.

Fractyl Health, Inc. announced that it will deliver an oral presentation of compelling preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, taking place May 13-17, 2025, in New Orleans, Louisiana.

Artiva Biotherapeutics, Inc announced that the Company will have a poster presentation on new longer-term Phase 1/2 data for AlloNK® (also known as AB-101) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma at the upcoming American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting taking place May 13-17, 2025, in New Orleans, Louisiana.

Neurogene Inc announced an oral presentation and participation in a fireside chat and panel discussion on critical gene therapy topics during the American Society for Gene and Cell Therapy (ASGCT) 28th Annual Meeting on May 13-17, 2025 in New Orleans.

Tharimmune, Inc., announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding TH104.

Purple Biotech Ltd. announced today that two posters reporting new NT219 data being presented at the American Association for Cancer Research (AACR 2025) Annual Meeting on Sunday and Monday, April 27-28, 2025.

Alpha Cognition Inc announced three upcoming presentations at the 2025 Alzheimer's Association International Conference (the "AAIC"), taking place July 27–31, 2025 in Toronto, Canada.

Guardant Health, Inc. announced the launch of Guardant360® Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis—including DNA, RNA, AI-powered PD-L1 and exome-wide methylation data—to provide researchers and cancer care teams with a more comprehensive view of cancer.

Schrödinger, Inc presented preclinical data on SGR-3515, its investigational Wee1/Myt1 co-inhibitor today at the American Association for Cancer Research (AACR) Annual Meeting 2025.

Chemomab Therapeutics, today reported data from two study abstracts that will be presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver, that will be held May 7–10, 2025, in Amsterdam, the Netherlands.

Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC).

Compass Therapeutics, Inc. announced its poster presentation entitled "Enhanced Efficacy of CTX-471, A CD137 Agonist Antibody, In Models of Immune Checkpoint Failure Via Simultaneous Blockade of Neo-Angiogenesis" at the American Association for Cancer Research (AACR) Annual Meeting, from April 25–30, 2025, at the McCormick Place Convention Center in Chicago, IL.

Evaxion Biotech A/S announces new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response.

Alto Neuroscience, Inc. announced multiple presentations at the Society of Biological Psychiatry (SOBP) Annual Meeting, in Toronto, Canada, held April 24-26, 2025.

Radiopharm Theranostics nnounced the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.

Pacira BioSciences, Inc. announced new data demonstrating its locally administered gene therapy candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function for up to two years following a single local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee.

IN8bio, Inc announced new preclinical data from its innovative γδ T cell engager (γδ-TCE) platform.

Jaguar Health, Inc. announced that Jaguar is hosting an investor webcast on Wednesday, April 30, 2025 at 8:30 AM Eastern to review the initial results of the proof-of-concept (POC) investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's plant-based anti-secretory prescription drug, in patients with the rare diseases microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) that were presented by Dr. Mohamad Miqdady on April 26, 2025 at the 11th Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates.

Mirum Pharmaceuticals, Inc announced that it will present data at three upcoming medical congresses. Digestive Disease Week (DDW) will be held in San Diego, May 3-6, 2025.

ImmunityBio, Inc. announced positive long-term results from its QUILT-3.032 study of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease.

Actinium Pharmaceuticals, announced preclinical results with ATNM-400 in prostate cancer models presented at the American Association for Cancer Research (AACR) Annual Meeting.

EXCLUSIVE: Artelo Biosciences Tells Benzinga Co. Announces Publication Of New Peer-Reviewing Research Demonstrating ART26.12's Effectiveness In Treating Psoriasis

SELLAS Life Sciences Group, announced that preclinical efficacy of SLS009 in TP53 mutated Acute Myeloid Leukemia (AML) cells are being presented in a poster session at the American Association for Cancer Research (AACR) taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.

Alnylam Pharmaceuticals, Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of its RNAi therapeutic vutrisiran for the treatment of wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Phathom Pharmaceuticals, Inc announced that the company will present real-world data for its first-in-class treatment VOQUEZNA® (vonoprazan) at Digestive Disease Week® (DDW) being held May 3–6, 2025, in San Diego, CA.

Zentalis® Pharmaceuticals, Inc. announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).

Zentalis® Pharmaceuticals, Inc. announced that Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback

TuHURA Biosciences, Inc today reported on poster presentations of Kineta Inc.'s ("Kineta") KVA12123 novel anti-VISTA antibody and TuHURA's IFx-Hu2.0 in advanced melanoma and at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL.

BriaCell Therapeutics Corp. is presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT™, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.

Alterity Therapeutics announced that David Stamler, M.D., Chief Executive Officer presented the ATH434-201 Phase 2 clinical trial results at the annual MSA Research Symposium hosted by University College London, Institute of Neurology in partnership with the MSA Trust of the U.K.

Kura Oncology, Inc. announced that the first patients have been dosed in KOMET-015, a Phase 1 clinical trial of ziftomenib, the Company's potent and selective, oral investigational menin inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure.

Senti Biosciences, Inc. today reported additional positive preliminary data from a Phase 1 clinical trial of SENTI-202, a potential first-in-class off-the-shelf Logic Gated selective CD33 OR FLT3 NOT EMCN chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, for the treatment of relapsed/refractory (R/R) hematologic malignancies including acute myeloid leukemia ("AML").

RedHill Biopharma Ltd. announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6).

Regeneron Pharmaceuticals, Inc. announced the upcoming presentation of 27 abstracts, including eight oral presentations on EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).

ADC Therapeutics SA announced data from preclinical studies of three exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6 (CLDN6), prostate-specific membrane antigen (PSMA), and Alanine, Serine, Cysteine Transporter 2 (ACST2) as presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.

Monte Rosa Therapeutics, announced the company will present preclinical data on the potential of its highly selective cyclin-dependent kinase 2 (CDK2)-directed molecular glue degrader, MRT-51443, to treat HR-positive/HER2-negative breast cancer at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25-30 in Chicago, IL.

Krystal Biotech, Inc announced that that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.

Eton Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, Eton's proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

Arvinas, Inc. today presented data from preclinical combination studies of ARV-393, the company's investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader.

argenx SE announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

Y-mAbs Therapeutics, Inc. announced the presentation of preclinical and translational pharmacokinetics (PK) data of CD38-SADA in a poster at the 2025 American Association of Cancer Research (AACR) Annual Meeting being held on April 25-30, 2025 in Chicago, IL.

Abpro Holdings, Inc. today unveiled preclinical data for ABP-102/CT-P72 in an oral presentation at the American Association for Cancer Research® (AACR) Annual Meeting 2025, in the New Drugs on the Horizon session.

Revolution Medicines, Inc announced new clinical data for zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC).

Merck announced results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Relmada Therapeutics, announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.

UroGen Pharma Ltd announced new data from the OPTIMA II Phase 2b study of UGN‑102 (mitomycin) for intravesical solution demonstrate clinically meaningful two-year duration of response (24.2 months) by Kaplan-Meier analysis.

UroGen Pharma Ltd. today highlights a duration of response of nearly four years from a long-term follow-up study with JELMYTO® (mitomycin) for pyelocalyceal solution, which is FDA-approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.

UroGen Pharma Ltd announced an updated 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, from the Phase 3 ENVISION trial of UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.

CG Oncology, Inc. announced that cretostimogene grenadenorepvec monotherapy data was presented at the Practice-Changing, Paradigm-Shifting Clinical Trials in Urology Plenary Session at the 2025 American Urological Association (AUA) Annual Meeting, in Las Vegas, Nevada.

Johnson & Johnson announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer.

Pfizer Inc. announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

UroGen Pharma Ltd announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC).

Protara Therapeutics, Inc. announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.

Tonix Pharmaceuticals Discontinued Enrollment And Terminated Phase 2 Catalyst Study Of Its TNX-1300 Product; The Company Is Evaluating New Study Designs And New Endpoints For Further Development Of TNX-1300

Ad hoc announcement pursuant to Art. 53 LR Molecular Partners announced the presentation of three posters at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25–30 in Chicago, IL.

Summit Therapeutics Inc announced that ivonescimab was approved by the Chinese Health Authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the Phase III clinical trial, HARMONi-2 or AK112-303.

Pyxis Oncology, Inc. announced robust preclinical data supporting the unique extracellular linker payload cleaving mechanism of action of micvotabart pelidotin (MICVO, formerly referred to as PYX-201) and validating MICVO's ongoing clinical development. MICVO is a first-in-concept antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix.

ALX Oncology Holdings Inc. announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial (IST) of the company's lead clinical candidate, evorpacept, in combination with standard-of-care rituximab and lenalidomide (R2) in patients with indolent and aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

Bolt Biotherapeutics announced results from its Phase 1 dose-escalation clinical study of BDC-3042 at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

Elevation Oncology, Inc. announced that its On-track to file IND application in 2026

Elevation Oncology, Inc. announced new preclinical proof-of-concept data for its novel HER3 antibody-drug conjugate (ADC), EO-1022.

Leap Therapeutics, Inc. announced it will present preclinical data of FL-501 in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois.

IO Biotech announced the presentation of new preclinical data for two vaccine candidates developed based on its T-win® platform at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois.

Zymeworks announced the presentation of six posters with new preclinical data from its preclinical, development-stage, and clinical programs at the American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025 in Chicago, IL.

Repare Therapeutics Inc announced the acceptance of two abstracts for mini-oral presentation and the acceptance of four abstracts for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

- Olema Pharmaceuticals, announced preclinical data demonstrating the anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer (NSCLC) models.

Nurix Therapeutics, Inc. announced multiple preclinical presentations at the American Association for Cancer Research (AACR) 2025 Annual Meeting supporting several programs, each with different drug targets for indications with central nervous system (CNS) involvement. The AACR Annual Meeting is being held from April 25-30, 2025, in Chicago, IL.

Autolus Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

Jazz Pharmaceuticals plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.1

PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authorization application for Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU).

ALX Oncology Holdings Inc announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 clinical trials.

Azitra, Inc announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago.

CERo Therapeutics Holdings, Inc. announces it will be presenting a poster at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting to be held May 30-June 3, 2025 at McCormick Place, Chicago, Ill.

Allarity Therapeutics, Inc. announced the presentation of a poster containing data on a new DRP for the monoclonal antibody drug daratumumab.

VYNE Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company's Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis.

Polyrizon Ltd.announced the successful preliminary safety study for a formulation of its PL-14 Allergy Blocker, marking a significant advancement in the product's development path.

Y-mAbs Therapeutics, Inc. announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial evaluating the Company's Self-Assembly and Disassembly ("SADA") Pre-targeted Radioimmunotherapy ("PRIT") platform for the treatment of patients with relapsed or refractory non-Hodgkin Lymphoma (r/r NHL).

Tenaya Therapeutics, Inc. announced interim data from its ongoing RIDGE (NCT06311708) natural history and seroprevalence study of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the Plakophilin 2 (PKP2) gene will be presented at the Heart Rhythm Society's annual Heart Rhythm meeting taking place in San Diego, CA from April 24-27, 2025.

Neurocrine Biosciences, Inc. announced publication of a post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrating the long-term safety profile and robust efficacy of INGREZZA® (valbenazine) capsules in adults aged 65 years and older with tardive dyskinesia (TD) in The Journal of Clinical Psychiatry.

Boston Scientific Corporation y announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF). Key findings from the study were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation.

Inventiva announced publication in the peer-reviewed medical journal Clinical Gastroenterology and Hepatology, of its analysis on new non-invasive biomarker signatures predictive of histology response following treatment with lanifibranor in patients with MASH and fibrosis.

NeuroSense Therapeutics issued a shareholder letter from Chief Executive Officer Alon Ben-Noon.

Senti Biosciences, Inc announced that it will host a conference call and webcast to discuss the new SENTI-202 Phase 1 clinical data being presented at the American Association for Cancer Research (AACR) Annual Meeting on Monday, April 28, 2025 at 8:30 AM ET.

AbbVie announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.

CERo Therapeutics Holdings, Inc. announces that Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado will be a key clinical trial site for the Company's Phase 1 clinical trial of CER-1236.

Genprex, Inc announced that it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois and online.

Kairos Pharma, Ltd provides a letter to stockholders from CEO John Yu, M.D

Ardelyx, Inc. announced that the company will present data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be held May 3-6, 2025, in San Diego.

Lucid Diagnostics announced positive data from a National Cancer Institute (NCI)-sponsored study demonstrating that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer (Barrett's Esophagus or BE) among at-risk patients without symptoms of chronic gastroesophageal reflux disease (GERD), such as heartburn.

Northstrive Biosciences Inc. a subsidiary of PMGC Holdings Inc. announced that it has received preliminary responses and commentary from the U.S. Food and Drug Administration ("FDA") regarding its scheduled Type B pre-Investigational New Drug ("pre-IND") meeting.

CG Oncology, Inc. announced it will host a conference call and live webcast at 8:00 am ET on April 28, 2025, to discuss results from the Phase 3 BOND-003 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) to be presented on April 26, 2025, at a Plenary Session at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.

Relmada Therapeutics, announced it will host a virtual key opinion leader (KOL) event on Monday, April 28, 2025 at 4:30 PM ET.

Tonix Pharmaceuticals presented data in an oral presentation at the World Vaccine Congress Washington 2025, held April 21-24, 2025, in Washington, D.C.

Dyne Therapeutics, Inc. announced that the European Commission (EC) has granted orphan drug designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD).

Oncolytics Biotech® Inc. announced that it will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep's anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) - the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options.

Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster prenstation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place May 30 – June 3, 2025, in Chicago, Illinois.

BioNTech SE announced that it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025.

Zealand Pharma A/S announced that the first participant has been enrolled in ZUPREME-2, a Phase 2b trial in people with overweight or obesity and type 2 diabetes comparing once-weekly subcutaneously administered petrelintide, a long-acting amylin analog, versus placebo with regards to efficacy and safety1.

Mineralys Therapeutics, Inc. announced that the New England Journal of Medicine (NEJM) published the detailed results from the Company's pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

Insmed Incorporated announced that positive results from the pivotal phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis were published in the New England Journal of Medicine (NEJM).

Jazz Pharmaceuticals plc announced that the company, along with its partners, will present seven abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 30-June 3, 2025, in Chicago and online.

Candel Therapeutics, Inc. announced that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL.

Arcus Biosciences, Inc announced that data from the ARC-20 study will be presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3, 2025.

Xilio Therapeutics, Inc. announced plans to present updated data from its ongoing Phase 2 clinical trial investigating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Verastem Oncology announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation.

Verastem Oncology announced that Initial safety and efficacy results from the trial of VS-7375 by partner GenFleet Therapeutics to be presented at the 2025 ASCO Annual Meeting

Corvus Pharmaceuticals, Inc announced that new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting, which is taking place May 7-10, 2025 in San Diego, CA.

- NeuroOne Medical Technologies Corporation announced that has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.

MetaVia Inc. announced that an abstract highlighting data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), has been accepted as a late-breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place May 7-10, 2025 in Amsterdam, the Netherlands.

CEL-SCI Corporation announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy* (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathways to a marketing application in Saudi Arabia.

Clearmind Medicine Inc.announced the initiation of its U.S. clinical trial site at the Yale School of Medicine's Department of Psychiatry.

Protara Therapeutics announced it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025, to review updated safety and efficacy data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including data from patients who have reached the 12-month evaluation timepoint.

Rezolute, Inc. announced that Enrollment on track and expected to be completed in May 2025

Rezolute, Inc. announced the DMC's recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital HI, without an increase in the study sample size.

UNITY Biotechnology, Inc. announced that the peer-reviewed journal NEJM Evidence published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME).

MIRA Pharmaceuticals, Inc announced a key development milestone that may significantly advance the Company’s topical drug pipeline: its novel topical formulation of Ketamir-2 demonstrated successful, dose-proportional drug release in a validated laboratory study, marking a critical step forward in the program’s progression toward clinical testing.

Cybin Inc announced additional strategic partnership agreements ("SPAs"), bringing the total to 18 clinical sites engaged to advance Cybin's multinational Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD.

Rein Therapeutics announced that the U.S. Patent and Trademark Office (USPTO) granted two new patents related to Rein's lead product candidate, LTI-03, a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling, which is administered through dry powder inhalation.

Atea Pharmaceuticals, Inc. announced that the full results from the Phase 2 clinical study of Atea's regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of hepatitis C virus (HCV) infection will be presented at the European Association for the Study of the Liver (EASL) Congress 2025.

Labcorp announced the expansion of its precision oncology portfolio with two solutions: Labcorp Plasma Detect for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of PGDx elio plasma focus Dx, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments.

Tiziana Life Sciences, Ltd announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS).

Summit Therapeutics Inc. announced that the Phase III clinical trial, HARMONi-6 or AK112-306, met its primary endpoint of progression-free survival (PFS).

Pharming Group N.V. announces that the National Institute for Health and Care Excellence (NICE) has issued positive final guidance recommending Joenja® (leniolisib) for reimbursement and use within the National Health Service (NHS) in England and Wales for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Arbutus Biopharma Corporation announced that five abstracts, including one late-breaker, have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7 - 10, 2025 in Amsterdam, Netherlands.

Recursion announced that it will present preliminary data during the 2025 Digestive Disease Week (DDW) meeting from its ongoing Phase 1b/2 clinical trial, TUPELO, which is evaluating the safety and preliminary activity of REC-4881 for the treatment of familial adenomatous polyposis (FAP).

Bristol Myers Squibb announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia.

OS Therapies announced that the US Food & Drug Administration ("FDA") granted the Company's meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma.

MetaVia Inc. reported additional top-line results from the multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), further demonstrating its potential as a best-in-class obesity drug.

Genprex, Inc announced that its research collaborators' abstract was published in the online Proceedings supplement of Cancer Research, a scientific journal published by the American Association for Cancer Research (AACR).

Palvella Therapeutics, Inc announced that the United States Patent and Trademark Office (USPTO) issued patent No. 12,268,673 for claims related to the Company's lead product candidate QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin).

BriaCell Therapeutics Corp is pleased to announce that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients.

Novocure announced that Optune Lua® has received a CE (Conformité Européenne)Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.

Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

Surmodics, Inc announced the publication of the TRANSCEND clinical trial, a global randomized study demonstrating the SurVeil™ drug-coated balloon (DCB) is non-inferior to the IN.

Aclaris Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.

Kymera Therapeutics, announced that it recently initiated dosing in its BroADen Phase 1b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD).

Exact Sciences Corp. announced the launch of Oncodetect™—a new test designed to detect molecular residual disease (MRD) across multiple solid tumors.

Compass Pathways plc announced that all participants have completed dosing in Part A of the COMP005 phase 3 trial for treatment resistant depression (TRD).

Lipella Pharmaceuticals Inc. announced positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10, for the treatment of oral lichen planus (OLP).

HUTCHMED (China) Limited announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification.

Design Therapeutics, Inc. announced that it will present an update on the progress of its DT-168 program for Fuchs endothelial corneal dystrophy (FECD) at Eyecelerator @ Park City 2025 on Friday, May 2, 2025, at 1:30 p.m. MT in Park City, UT.

NeuroNOS a subsidiary of Beyond Air announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-102, for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with Autism Spectrum Disorder (ASD).

NeuroNOS, a subsidiary of Beyond Air announced that Plan to initiate first-in-human U.S. clinical trials of lead drug candidate for treating ASD in 2026

ImmunityBio, Inc. announce new clinical findings for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) and updated data on papillary disease without CIS at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29.

Achieve Life Sciences, Inc announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults.

Coya Therapeutics, Inc. announced publication of the results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya's investigational biologic combination to suppress pro-inflammatory myeloid cells, enhance Treg suppressive function, and modulate T cell proliferation, in an in vitro system of human immune cells obtained from healthy donors.

Johnson & Johnson announced that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas.

Vaccinex, Inc. announced that it will present exciting new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies, corresponding with improved survival benefit in patients with melanoma and head and neck cancer at the 2025 Annual Meeting of American Association for Cancer Research (AACR) in Chicago on April 29, 2025.

Enlivex Therapeutics Ltd. announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage.

Gilead Sciences, Inc. announced positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10).

IMUNON, Inc. announced that an abstract highlighting new, highly encouraging, Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 to treat women with newly diagnosed advanced ovarian cancer was accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Tempest Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to TPST-1495, the company's novel dual receptor inhibitor of prostaglandin (PGE2) signaling, for the treatment of patients with Familial Adenomatous Polyposis (FAP).

Elutia Inc. announced the initiation of an EluPro™ clinical study designed to collect patient outcome data in real-world clinical practice.

Corcept Therapeutics Incorporated announced the publication of findings from the prevalence phase of the CATALYST trial in Diabetes Care, a peer-reviewed journal published by the American Diabetes Association.

Chemomab Therapeutics, announced that clinical data on nebokitug (CM-101) for the treatment of patients with primary sclerosing cholangitis (PSC) will be presented at major upcoming scientific conferences including DDW25, Digestive Disease Week 2025®; EASL 2025, the Annual Congress of the European Association for the Study of the Liver; and BSG LIVE'25, the British Society of Gastroenterology's annual meeting. Chemomab will report information on the content of the presentations after the meeting embargoes lift.

Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Anavex Life Sciences Corp. announced that Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of Anavex's Scientific Advisory Board gave an oral presentation titled, "Oral Blarcamesine Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial" at the 9th International Conference on Alzheimer's Disease and Related Disorders in the Middle East.

Arvinas, Inc. announced that new preclinical combination data for ARV-393 will be presented at the American Association for Cancer Research® (AACR) Annual meeting, April 25-30, 2025 in Chicago, Illinois.

AstraZeneca and Daiichi Sankyo announces Positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer.

Immunovant, Inc announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE.

Viatris Inc. announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan.

Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications.

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg.

GSK announced that Health Canada has approved Jemperli (dostarlimab for injection) in combination with chemotherapy (carboplatin and paclitaxel) for the treatment of adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy.

Jaguar Health, Inc. and Napo Therapeutics announced that preliminary results from the ongoing pediatric investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for various congenital diarrheal disorders (CDD), including MVID and SBS with intestinal failure (SBS-IF), will be presented by Dr. Mohamad Miqdady at the April 24-26, 2025 Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates.

NANO-X IMAGING announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nanox.ARC X, its new multi-source digital tomosynthesis system.

Alector, Inc. announced the completion of enrollment in PROGRESS-AD, a 76-week Phase 2 clinical trial evaluating the safety and efficacy of AL101/GSK4527226 in slowing disease progression in individuals with early Alzheimer's disease (AD).

Actuate Therapeutics, Inc announced that data on elraglusib in advanced salivary gland carcinoma will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.

Calidi Biotherapeutics Inc. announced that that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201.

Palatin Technologies, Inc. announced positive appetite suppression results from its BMT-801 Phase 2 obesity study.

uniQure N.V announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130 for the treatment of Huntington's disease, a rare, inherited neurodegenerative disorder for which there are currently no disease-modifying therapies available.

Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for the IRAK4 degrader GS-6791/NX-0479

Addex Therapeutics announced today that following the previously announced termination of development of ADX71149 (JNJ-40411813) in epilepsy, its partner Janssen Pharmaceuticals, Inc. (now known as J&J Innovative Medicine) has return all development and commercialization rights to ADX71149 (JNJ-40411813) and the partnership between the two companies has been terminated.

Pfizer Inc. that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD).

Clearmind Medicine Inc. announced it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of Medicine. The first in human clinical trial will investigate the safety, tolerability and full pharmacokinetic profile of Clearmind's innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients

RenovoRx, Inc announced that it is increasing production of its FDA-cleared RenovoCath catheter-based device in order to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists.

Aditxt, Inc. announced that its subsidiary, Pearsanta, Inc. ("Pearsanta"), has received Institutional Review Board (IRB) approval from WCG Clinical to initiate a prospective clinical study evaluating the Mitomic® Endometriosis Test (MET), a novel blood-based diagnostic designed to aid in the early detection of endometriosis.

AptarGroup, Inc. announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform.

PDS Biotechnology nnounced that preclinical immune response data with a novel Infectimune® based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting, taking place May 3-7, 2025, in Honolulu, Hawaii.

MIRA Pharmaceuticals announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.

BioVie Inc announced that patient enrollment is now open for the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in patients with Parkinson's disease (PD) who haven't been treated with carbidopa/levodopa.

Cardiol Therapeutics Inc. announced that Northwestern University has enrolled the first patient in the pivotal Phase III MAVERIC trial ("MAVERIC") evaluating Cardiol's lead drug candidate CardiolRx™ for the prevention of recurrent pericarditis.

BriaCell Therapeutics Corp announces new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.

INmune Bio Inc announced a major intellectual property milestone with respect to its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™.

Purple Biotech Ltd. announced the publication of an independent study titled "IRS2 as a driver of brain metastasis in colorectal cancer: a potential target for novel therapeutic strategies" in the peer reviewed journal, Neuro Oncology. NT219 is a first-in-class small molecule drug designed to target key cancer resistance mechanisms by degrading IRS1/2 and blocking downstream signaling towards AKT and b-catenin, as well as STAT3 survival pathways.

Q32 Bio Inc. announced that the Company has dosed the first patients in both the Part A open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with alopecia areata (AA).

Cullinan Therapeutics, announced that the European Medicines Agency (EMA) approved the Company's Clinical Trial Application (CTA) for CLN-978.

RedHill Biopharma Ltd. announced the new publication[2] of positive in vivo data, in the journal Diabetes, Metabolic Syndrome and Obesity, in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet (HFD)-Induced Obesity and Glucose Intolerance".

EXCLUSIVE: MIRA Pharmaceuticals Ketamir-2 Shows Efficacy In Diabetes-Associated Nerve Damage In Animal Study

Cardiff Oncology, Inc. announced completion of patient enrollment in the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care (SoC) for the treatment of first-line RAS-mutated metastatic colorectal cancer (mCRC).

Hyperfine, Inc announced the enrollment of initial patients in the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study.

Scilex Holding Company announced that it has received approval of a New Drug Submission (NDS) from the Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB®'s acute treatment of migraine with or without aura in Canada.

BioCardia, announced that the study's independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed.

Hoth Therapeutics, Inc. announced positive interim data from the open-label portion of its Phase 2a clinical trial, CLEER-001, evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors.

Mural Oncology plc announced that following review of data from its phase 2 ARTISTRY-6 trial in melanoma and previously announced results from the phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, the company is discontinuing all clinical development of nemvaleukin alfa and plans to immediately commence the exploration of strategic alternatives focused on maximizing shareholder value. Mural has engaged Lucid Capital Markets, LLC to act as its financial advisor in connection with the exploration of strategic alternatives.

Ensysce Biosciences, Inc. announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection.

Tectonic Therapeutic, announced that it will make a late-breaking oral presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress.

ImmunityBio, Inc announced that it has completed multiple submissions to the FDA including an sBLA for BCG-unresponsive NMIBC in papillary disease and an EAP for ANKTIVA® (nogapendekin alfa inbakicept-pmln) for the treatment of lymphopenia.

Plus Therapeutics, Inc. announces the online availability of new data on its lead compound REYOBIQ™ (rhenium Re186 obisbemeda) in an abstract for both an oral presentation and a poster to be presented at the Nuclear Medicine and Neurooncology conference to be held May 9-10, 2025 in Vienna, Austria.

MetaVia Inc. announced positive results from the 4-week multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.

Precision BioSciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PBGENE-HBV, the Company's lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes.

Rein Therapeutics announced a publication highlighting the therapeutic potential of Caveolin-1-related peptide LTI-2355 in Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F) in the peer-reviewed journal, Biomedicines.

Bluejay Diagnostics, Inc. announced acceptance of an abstract related to the Symphony IL-6 Test, the company's lead product candidate, for presentation at the Society of Academic Emergency Medicine (SAEM) Annual Meeting, taking place in Philadelphia May 13-16, 2025.

Mind Medicine announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD.

Skye Bioscience, Inc announced new preclinical data for its novel CB1 antibody, nimacimab.

Sanofi today shared new progress from its mid- to late-stage respiratory pipeline, including preliminary phase 2 results for amlitelimab in adults with moderate-to-severe asthma.

Exicure, Inc announced that GPCR Therapeutics USA, a subsidiary of Exicure Inc., has dosed the 19th patient in its ongoing Phase 2 clinical trial evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for the mobilization of stem cells in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT) (NCT05561751).

Bristol Myers Squibb announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2).

Mirum Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of LIVMARLI® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).

Aditxt, Inc announced that a recently completed study conducted by the Mayo Clinic further validates the preclinical findings of ADI-100, the lead therapeutic candidate developed by Aditxt's wholly owned subsidiary, Adimune™, Inc. ("Adimune").

NeOnc Technologies announced that Trial Read-Out Data Expected in Early 2026

NeOnc Technologies announced that it expects full enrollment in its Phase 2a clinical trial for its lead therapeutic candidate, NEO100-01 in September. Only six patients remain to complete the trial's 25-patient enrollment target.

UroGen Pharma Ltd announced that data on investigational drug UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution and UGN-301 (zalifrelimab) will be presentedat the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29.

Ainos, Inc. announced significant progress in advancing its oral interferon drug platform, VELDONA® in the rare disease space.

Fate Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN).

Fate Therapeutics, Inc Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025

INmune Bio Inc. a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms.

Soligenix, Inc announced interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Relmada Therapeutics, announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.

Soleno Therapeutics, Inc announced the U.S. commercial availability of VYKAT™ XR (diazoxide choline) extended-release tablets, the company's treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025.

NanoViricides, Inc. announced that it has begun evaluation of its clinical drug NV-387 for the treatment of the Measles virus.

Verve Therapeutics announced positive initial data from the Heart-2 Phase 1b clinical trial of VERVE-102. The Heart-2 Phase 1b clinical trial is evaluating patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD), two populations that require deep and durable reductions of low-density lipoprotein cholesterol (LDL-C) levels in the blood.

Ironwood Pharmaceuticals, Inc announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support.

Exact Sciences Corp. announced the publication of a comprehensive review in JAMA Oncology that strengthens the evidence supporting the Oncotype DX Breast Recurrence Score test.

IDEAYA Biosciences, Inc. announced a successful FDA Type D meeting on the Phase 3 registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma (UM).

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.

Amgen announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy met its primary endpoint at a planned interim analysis.

Biodexa Pharmaceuticals Expects Initiation Of Phase 3 Registrational Study Of eRapa In FAP, Initiation Of IIT Of Tolimidone In T1D At University Of Alberta As 2025 Clinical Milestones

Palvella Therapeutics, Inc. announced QTORIN™ rapamycin 3.9% anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) was featured by Dr. Amy Paller in an oral presentation at the 15th World Congress of Pediatric Dermatology in Buenos Aires, Argentina. Dr. Amy Paller is the Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, and Principal Investigator of the NIH-funded Skin Biology and Diseases Resource-based Center at Northwestern University's Feinberg School of Medicine and has served as President of the Society for Investigative Dermatology (SID), the Society for Pediatric Dermatology (SPD), the International Eczema Council (IEC), the Pediatric Dermatology Research Alliance (PeDRA), and the Women's Dermatological Society (WDS).

Verve Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VERVE-102 for the treatment of patient groups with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol (LDL-C).

Perspective, Therapeutics, Inc. announced that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), as monotherapy in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans.

argenx SE announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Protara Therapeutics, Inc. announced that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting taking place from April 26, 2025 to April 29, 2025 in Las Vegas.

DexCom, Inc announced today the FDA has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring System for people over the age of 18 with diabetes in the United States.

Clearmind Medicine Inc announced . that it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of Medicine.

Theriva Biologics announced the presentation of the previously disclosed blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Oculis Holding AG announced that it has completed enrollment in both Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the U.S. Food and Drug Administration (FDA).

Arcturus Therapeutics Holdings Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine.

OS Therapies announced positive data in the prevention or delay of amputation during the treatment of primary osteosarcoma for OST-HER2 combined palliative radiation in dogs with unresected appendicular osteosarcoma.

Alterity Therapeutics announced that new presentations related to its Multiple System Atrophy (MSA) program were delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting, one of the premier global neurology meetings.

Palatin Technologies, Inc. announced that data from the Phase 2b BREAKOUT study will be presented today at the National Kidney Foundation Spring Meeting in Boston, MA.

BrainStorm Cell Therapeutics Inc. announced the submission of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) for NurOwn®, the company's autologous mesenchymal stem cell therapy for amyotrophic lateral sclerosis (ALS).

Harrow announced an expansion of its VEVYE® Access for All("VAFA") program to include patients currently prescribed Klarity-C Drops®, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx®, Harrow's compounding subsidiary.

Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended that the Company's Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification.

Gain Therapeutics, Inc. announced that an oral presentation as well as a poster were presented at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders held April 1-5, 2025, in Vienna, Austria.

IDEAYA Biosciences, Inc announced the initiation of a Phase 1/2 expansion in the clinical trial evaluating IDE397, its investigational, potential first-in-class, small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC) based on preliminary safety and clinical efficacy data.

Halozyme Therapeutics, Inc. announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting.

Palisade Bio, Inc. announced the completion of enrollment and dosing in all five Phase 1a SAD cohorts, all four MAD cohorts, and the food effects crossover in the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

Microbot Medical Inc presented for the first time the data from its ACCESS-PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting.

NeuroSense Therapeutics, Ltd. announced promising new findings from its Phase 2b PARADIGM clinical trial.

CERo Therapeutics Holdings, Inc. announces its first clinical trial site for the Company's Phase 1 clinical trial of CER-1236.

Quest Diagnostics announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia.

Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio's Phase 1b clinical trial (NCT 06014086) for Phio's lead product candidate, PH-762.

Grace Therapeutics, Inc. announced details of the Company's Type C meeting with the U.S. Food and Drug Administration (FDA).

Context Therapeutics Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95, a mesothelin ("MSLN") x CD3 T cell engaging ("TCE") bispecific antibody designed to target mesothelin-expressing cancers. The Company anticipates sharing initial data for the CT-95 Phase 1 trial in mid-2026.

Tonix Pharmaceuticals Holding Corp. announced a collaborative research agreement under which Tonix and Makana will study Tonix's anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana's human-compatible organs and cells for the treatment of organ failure.

Atea Pharmaceuticals, Inc. announced that the first patient has been dosed in C-BEYOND, Atea's Phase 3 trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of adults with chronic hepatitis C virus (HCV).

Assembly Biosciences, Inc. announced data from its herpes simplex virus (HSV) program featured in three poster presentations at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) taking place in Vienna, Austria, on April 11-15, 2025.

MediciNova, Inc announced enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS).

Annexon, Inc. today presented data for its late-stage targeted therapy for GBS and showcased new disease education activities at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California.

NeOnc Technologies Holdings, Inc announced that its Phase I clinical trial of NEO212, a development-stage bio-conjugated therapeutic for brain cancer, is nearing full enrollment. The final cohort (Cohort 5) is expected to complete the study's dosing protocol, marking a major milestone in the drug's development timeline.

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

Avidity Biosciences, Inc. announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug designation (ODD) to delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1), an investigational treatment designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies.

SELLAS Life Sciences Group, announced Cohort 3 data from the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD.

Outlook Therapeutics, Inc announced that he FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025.

Catalyst Pharmaceuticals, Inc today reported that its sub-licensee in Canada, Kye Pharmaceuticals, Inc. (Kye), has announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®, a novel corticosteroid treatment for Duchenne muscular dystrophy (DMD), for review.

Harmony Biosciences Holdings, Inc announced the presentation of updated data from its Open-Label Extension (OLE) study (ZYN2-CL-017) evaluating the safety and effectiveness of ZYN002 in children, adolescents, and adults with Fragile X syndrome (FXS).

Rallybio Corporation announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT).

SCYNEXIS, Inc. announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being held from April 11-15, 2025.

Recursion announced that the first patient has been dosed in the Phase 1 EXCELERIZE clinical study evaluating REC-3565 for the treatment of relapsed or refractory B-cell lymphomas.

Clene, Inc. announced new evidence of remyelination and neuronal repair in MS participants following treatment with CNM-Au8® 30 mg from analyses of the VISIONARY-MS Trial long-term open-label extension study.

Opus Genetics, Inc. announced one-month clinical data from the first pediatric patient treated with its investigational gene therapy, OPGx-LCA5, in a Phase 1/2 open-label trial for LCA5-related inherited retinal disease (IRD).

NeuroPace, Inc. announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, which showed an 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).1

TG Therapeutics, Inc. announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below.

Kura Oncology, Inc announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM 1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025.

Cartesian Therapeutics announced 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG).

Enanta Pharmaceuticals, Inc announced that data from the Company's Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV) has been accepted for an oral presentation as an ePoster at the European Society of Clinical Microbiology & Infectious Diseases Global 2025 (ESCMID, formerly ECCMID) being held April 11-15, 2025 in Vienna, Austria.

Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV® (tesamorelin for injection).

Lipella Pharmaceuticals Inc. announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP).

AbbVie announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients.

NeuroSense Therapeutics Ltd. provides a business update.

Halozyme Therapeutics, Inc. announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

Inspira™ Technologies announced the successful completion of the first human treatment using its U.S. Food and Drug Administration-cleared INSPIRA™ ART100 system in a critical life-support procedure.

Allogene Therapeutics, Inc announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA)

NKGen Biotech, Inc. announced the oral presentation of updated Phase 1 clinical data from the Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate AD at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2025) in Vienna, Austria.

Tharimmune, Inc. announced preclinical data from its expanded pipeline with HS1940, a dual-target multispecific biologic engineered to bind to both Programmed Death-1 (PD-1) and Vascular Endothelial Growth Factor (VEGF), and HS3215, a dual-target biologic binding to Human Epidermal Growth Factors 2 (HER2) and 3 (HER3) receptors.

Amneal Pharmaceuticals, Inc announced a new analysis of the pivotal RISE-PD Phase 3 study showed that patients who successfully converted to CREXONT from immediate release (IR) carbidopa/levodopa (CD/LD) experienced statistically significant improvements in sleep quality.

errica Pharmaceuticals Inc provided a business update.

ALX Oncology Holdings Inc announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.

Vanda Pharmaceuticals Inc announced participation at the American Academy of Neurology (AAN) Annual Meeting, to be held in San Diego, California from April 5 through April 9, 2025.

TG Therapeutics, Inc. announced the publication of two journal articles one describing the evolution of CD20 treatments for multiple sclerosis (MS) and the other detailing the experience of seven individuals with MS who switched to BRIUMVI® (ublituximab-xiiy) from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.

CureVac N.V announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small cell lung cancer (sqNSCLC).

iBio, Inc announced data from a non-GLP non-human primate (NHP) pharmacokinetics (PK) study suggesting IBIO-600, the company's novel lead asset and a potentially best-in-class long-acting anti-myostatin antibody designed for subcutaneous administration, could provide a significantly extended half-life in humans and a weight loss treatment option while preserving and promoting muscle growth.

Rhythm Pharmaceuticals, Inc. announced positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for the treatment of acquired hypothalamic obesity.

Pharvaris provided a business update.

Lexeo Therapeutics, Inc announced positive interim data across all dose cohorts of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. .

Rhythm Pharmaceuticals, Inc. announced the Company will hold a conference call and webcast on Monday, April 7, 2025 at 8:00 a.m. ET to disclose topline results from the Pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.

Beam Therapeutics Inc. presented additional data from the Phase 1/2 clinical trial of BEAM-302 in patients with alpha-1 antitrypsin deficiency (AATD) at the 2025 Alpha-1 Foundation 7th Global Research Conference and 10th Patient Congress, taking place April 4-5, 2025, in Lisbon, Portugal.

Biohaven announced that it will present 13 abstracts at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025 in San Diego, California.

Anavex Life Sciences Corp. announced that over three years of continuous treatment with blarcamesine (ANAVEX®2-73) demonstrated significantly amelioration on clinical decline showing continued clinically and meaningful benefit for early Alzheimer's disease patients.

Sonnet BioTherapeutics announced positive safety results of SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the SB221 study).

NeuroSense Therapeutics, Ltd. announced that two members of its Scientific Advisory Board will present new data from the Company's Phase 2b trial during the General Neurology and Late Breaker sessions at the 77th Annual American Academy of Neurology (AAN) Meeting.

Elutia Inc. announced that EluPro™, the first ever FDA-cleared antibiotic-eluting bioenvelope was honored with a 2025 Bronze Edison Award™ for its innovative approach to reducing post-surgical complications.

Johnson & Johnson announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1

Arvinas, Inc. today presented data from the first-in-human clinical trial of ARV-102, the Company's investigational PROteolysis TArgeting Chimera (PROTAC) leucine-rich repeat kinase 2 (LRRK2) degrader.

Axsome Therapeutics, Inc announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California..

Annexon, Inc. today highlights the company's leadership in advancing clinical research and education for GBS at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.

Aldeyra Therapeutics, Inc announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.

Greenwich Lifesciences Provides Update On Its Phase III Clinical Trial, Flamingo-01, Which Is Evaluating GLSI-100, An Immunotherapy To Prevent Breast Cancer Recurrences

Akebia Therapeutics®, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL® (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).

Cingulate announced that it held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Amneal Pharmaceuticals, Inc. announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson's disease (PD) to their national prescription drug formularies.

Pacira BioSciences, Inc. announced the first patient has been dosed in the Phase 2 ASCEND study of PCRX-201 (enekinragene inzadenovec) for the treatment of osteoarthritis, or OA, of the knee.

Enlivex Therapeutics Ltd. announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.

Vera Therapeutics, Inc announced that it has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN).

Alterity Therapeutics announced that an oral presentation and a poster presentation related to Alterity's clinical programs in Multiple System Atrophy (MSA) will be delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting taking place April 5 - 9, 2025 in San Diego, CA.

Intellia Therapeutics announced the first patient has been dosed in MAGNITUDE-2, a global, pivotal Phase 3 trial of nexiguran ziclumeran (nex-z) for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN).

Incannex Healthcare Inc announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA).

Castle Biosciences, announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company's DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma.3,4

BeiGene, Ltd announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer.

Neurogene Inc announced a peer-reviewed publication on its EXACT™ transgene regulation technology.

Mesoblast today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.

Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

BioMarin Pharmaceutical Inc announced that the Phase 3 PEGASUS trial evaluating PALYNZIQ® (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone.

Alpha Tau Medical Ltd. announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology.

Denali Therapeutics Inc announced that the company's initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

Tiziana Life Sciences, Ltd. announced dosing has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2 trial evaluating intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

Palvella Therapeutics, Inc announced a late-breaking oral presentation at the upcoming 15th World Congress of Pediatric Dermatology, taking place April 8-11, 2025, in Buenos Aires, Argentina..

Hoth Therapeutics, Inc. announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer's candidate, HT-ALZ, in improving cognitive function and reducing neuroinflammation in Alzheimer's disease (AD).

Quoin Pharmaceuticals Ltd. announces additional highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study.

Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease.

Acumen Pharmaceuticals, presented extended results from its validated research-use plasma pTau217 assay to screen potential participants in the ongoing Phase 2 ALTITUDE-AD clinical trial of sabirnetug, showing this strategy has performed as intended.

Vigil Neuroscience presented data highlighting its oral small molecule program, including its lead clinical candidate VG-3927, in two oral presentations at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases being held April 1 – April 5 in Vienna, Austria.

AC Immune SA announced additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson's disease (PD).

Greenwich LifeSciences announced the following update on FLAMINGO-01 open label immune response data.

Edgewise Therapeutics, Inc announced positive top-line data of EDG-7500 from the Phase 2 CIRRUS-HCM four-week trial in participants with obstructive or nonobstructive HCM.

Applied DNA Sciences, announced that Applied DNA Clinical Labs (ADCL), its wholly-owned clinical laboratory subsidiary, is repositioning its TR8™ PGx pharmacogenomics testing service to offer tailored subpanels for indication-specific use cases in addition to full panel testing.

Connect Biopharma Holdings announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.

Castle Biosciences will share data via two poster presentations at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology (EADO) Congress, being held April 3-5, 2025, in Athens, Greece.

Inventiva announced the completion of patient enrollment in its NATiV3 Phase 3 clinical trial with the randomization of the last patient in the main cohort.

GRI Bio reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF).

Aquestive Therapeutics, Inc released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions.

RenovoRx, Inc. provided business updates

Moleculin Biotech, Inc., announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML).

Clearmind Medicine Inc. today the launch of its Electronic Data Capture (EDC) system to support its Phase I/II clinical trial of its MEAI-based treatment for Alcohol Use Disorder (AUD).

Candel Therapeutics, Inc. announced the publication of a manuscript reporting the results of a phase 1b clinical trial exploring safety and tolerability of the combination of CAN-2409 plus prodrug (valacyclovir) and nivolumab, in addition to standard of care (neurosurgery, radiotherapy, and temozolomide), in patients with newly diagnosed high-grade glioma.

MIRA Pharmaceuticals,announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain.

Cognition Therapeutics, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.

Cardiol Therapeutics Inc. announced today its year-end 2024 update on operations following the filing of its audited Financial Statements and Management's Discussion and Analysis for the year ended December 31, 2024.

Alkermes plc announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH).

Fractyl Health, Inc. announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study.

Compass Therapeutics, Inc. announced statistically significant top-line data on the primary efficacy endpoint for COMPANION-002, the Company's ongoing Phase 2/3 randomized trial of tovecimig (formerly CTX-009) in combination with paclitaxel in patients with advanced BTC.

Axsome Therapeutics, Inc. announced results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).

Apellis Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases.

Pfizer Inc announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age