FDA Calendar

Actuate Therapeutics, Inc. announced the publication of new data in Clinical Cancer Research from a Phase II study (NCT05010629) evaluating elraglusib in combination with carboplatin or cisplatin (with or without sequential pembrolizumab priming) in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma and other subtypes.

Gilead Sciences, Inc. announced positive topline results from the Phase 3 ARTISTRY-2 trial.

Hyperfine, Inc. announced that it has received FDA clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence.

Quince Therapeutics, Inc announced that the last patient has completed their last visit in the company's pivotal Phase 3 NEAT (Neurological Effects of eDSP in Subjects with A-T; NCT06193200/IEDAT-04-2022)clinical trial of its lead asset, encapsulated dexamethasone sodium phosphate (eDSP), in patients with Ataxia-Telangiectasia (A-T).

Fortress Biotech, Inc announced that the U.S. Food and Drug Administration ("FDA") has accepted the resubmission of the New Drug Application ("NDA") for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.

sanofi announced Results from the PERSEUS phase 3 study (clinical study identifier: NCT04458051) showed that tolebrutinib did not meet its primary endpoint in delaying time to 6-month composite confirmed disability progression (cCDP) in participants with primary progressive multiple sclerosis (PPMS), which represents 10% of the overall multiple sclerosis patient population. Based on these results, Sanofi will not pursue regulatory registration for PPMS.

TuHURA Biosciences, Inc. announced that Kintara's REM-001 clinical trial of ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety with signs of clinical efficacy following eight weeks of follow-up for such patients.

Medicus Pharma Ltd. is pleased to announce that its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat nodular basal cell carcinoma (BCC) of the skin, has successfully completed enrolment of ninety (90) patients in the United States.

FibroGen, Inc. announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS).

Vanda Pharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP).

RedHill Biopharma Ltd. announced positive in vivo results, indicating that opaganib combined with venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cells by half compared to controls, and further demonstrates opaganib's potential as an add-on therapy to venetoclax in venetoclax-resistant CLL.

Radiopharm Theranostics announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases.

Abpro Holdings, Inc. announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for ABP-102/CT-P72, a HER2 × CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity. Pending regulatory clearance, this IND will support the initiation of a phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers.

Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision.

Kyverna Therapeutics, announced positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (‘miv-cel', formerly KYV-101), a fully human, autologous CD19-targeting CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome (SPS).

OS Therapies Inc. announced that it held a successful Type C meeting with the United States Food & Drug Administration (FDA) regarding the Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program').

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen.

Palvella Therapeutics, Inc announced positive topline results from the Company's Phase 2 TOIVA study of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of cutaneous venous malformations (cutaneous VMs).

argenx SE announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued.

Immunome, Inc. announced the company will host a conference call and webcast on Monday, December 15, 2025 at 8:30 am ET to disclose the topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.

Kyverna Therapeutics, announced it will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 am ET to review topline results from the registrational Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (SPS).

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg.

Tiziana Life Sciences, Ltd. announces that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer's clinical trial and plans to dose the first patient next week.

Eli Lilly and Company announced updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant), an oral estrogen receptor antagonist, in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer (MBC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor.

Mineralys Therapeutics, Inc. announced today that the manuscript highlighting the Company's Phase 3 Launch-HTN clinical trial evaluating lorundrostat for the treatment of uncontrolled or treatment-resistant hypertension, was featured in JAMA's inaugural "Research of the Year Roundup," a curated collection of the most impactful studies published between October 2024 and September 2025.

Actinium Pharmaceuticals, Inc. announced the presentation of new preclinical data for ATNM-400, its first-in-class Actinium-225 (Ac-225) based antibody radioconjugate, at the 2025 San Antonio Breast Cancer Symposium (SABCS).

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV based on the Phase 3 ZENITH study.

Cytokinetics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.

Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for its Winnipeg, Canada facility to be added as the drug product manufacturing and testing site for raxibacumab, a monoclonal antibody for the treatment and prophylaxis of inhalational anthrax.

Arcus Biosciences, Inc announced the discontinuation of the Phase 3 STAR-221 study, being conducted in partnership with Gilead Sciences, Inc., due to futility.

Acadia Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.

BeyondSpring Inc. announced results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC).

Relay Therapeutics, Inc. announced a subset analysis of interim clinical data for zovegalisib (RLY-2608), the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα.

BioCryst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years.

ImmunityBio announced that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. announced the publication of positive results from a pivotal Phase 3 trial evaluating its investigational single-dose, oral antibiotic zoliflodacin for the treatment of uncomplicated urogenital gonorrhea in The Lancet.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

Tenaya Therapeutics, Inc. announced interim data from the ongoing RIDGE™-1 Phase 1b/2 clinical trial of TN-401 gene therapy for the potential treatment of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC), a form of arrhythmogenic cardiomyopathy (ACM) that primarily impacts the right ventricle, caused by mutations in the plakophilin-2 gene, PKP2.

Tenaya Therapeutics, Inc announced it has received official notification from the U.S. Food and Drug Administration (FDA) that the clinical hold on the MyPEAK-1™ Phase 1b/2a clinical trial of TN-201 has been removed. .

Actinium Pharmaceuticals is advancing its Trop-2–targeted ATNM-400 construct into Phase 1/2 trials across the United States and Australia, marking an important step as the company broadens its presence in solid-tumor radiopharmaceuticals.

Celcuity Inc announced updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR ("PAM") inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA wild-type ("WT"), advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

Personalis, Inc. announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell.

MAIA Biotechnology, Inc. announced that the first patient has been dosed in the Company's THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).

OKYO Pharma is pleased to announce new analyses of corneal images from the recently completed placebo-controlled, randomized, double-masked, Phase 2 clinical trial of urcosimod in neuropathic corneal pain (NCP).

Praxis Precision Medicines, Inc. announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026.

TransCode Therapeutics, Inc. announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.

Aligos Therapeutics, Inc announced positive data from four presentations, including two oral presentations, at the HEP-DART 2025 Meeting, being held December 7 – 11, 2025 in Honolulu, Hawaii.

Elicio Therapeutics, Inc. nnounced that analysis of a subset of patients in the ongoing Phase 2 AMPLIFY-7P trial has demonstrated that a majority of evaluated patients (13 out of 15) treated with ELI-002 7P induced antigen spreading targeting non-mKRAS neoantigens that are not present in the ELI-002 7P targeted immunotherapy.

Atossa Therapeutics, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted Rare Pediatric Disease ("RPD") designation to (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy ("DMD").

Rhythm Pharmaceuticals, Inc. announced positive preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

Atai Beckley announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company's intellectual property estate and long-term exclusivity for the program.

BeyondSpring Inc. announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study (Lancet Resp Med 12:775, 2024), showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC) who progressed after anti-PD-(L)1 immunotherapy.

Corbus Pharmaceuticals announced the completion of the single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 and the initiation of a Phase 1b dose-range finding study ("CANYON-1"), with completion expected in summer 2026.

Rezolute, Inc. announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI).

Kymera Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-621, its first-in-class, oral STAT6 degrader, for the treatment of moderate to severe atopic dermatitis (AD).,

Immatics N.V. announced updated Phase 1a dose escalation data from its second-generation PRAME cell therapy, IMA203CD8, in heavily pre-treated patients with solid tumors.

Purple Biotech Ltd. today reported positive new preclinical data from its CAPTN-3 tri-specific antibody platform presented at the ESMO Immuno-Oncology (ESMO IO) Congress 2025.

AC Immune SA announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of its wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in early Parkinson's disease (PD).

Biohaven Ltd announced that it presented clinical safety and efficacy data for BHV-1510 at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress, taking place from December 10-12, 2025, in London, United Kingdom.

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo®(nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).

Eli Lilly and Company announced positive topline results from the Phase 3 TRIUMPH-4 clinical trial evaluating the safety and efficacy of the two highest investigational doses of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, in adults with obesity or overweight and knee osteoarthritis, and without diabetes, as an adjunct to healthy diet and physical activity.

IDEAYA Biosciences, Inc announced it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company's investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer's crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).

Serina Therapeutics announced that it has submitted a complete response to the U.S. Food and Drug Administration's ("FDA") clinical hold letter for SER-252, the Company's lead program for advanced Parkinson's disease.

Aardvark Therapeutics, Inc. announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal clinical trial assessing ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS).

GRI Bio, Inc announced positive topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

Quince Therapeutics, Inc announced the publication of a summary of early-stage clinical studies of its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient's own red blood cells), in pulmonary and inflammatory bowel disorders (IBD) in the scientific journal Frontiers in Drug Delivery.

Rhythm Pharmaceuticals, Inc. announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).

Corbus Pharmaceuticals announced the Company's plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025.

Jaguar Health, Inc announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, the company's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy.

Journey Medical Corporation announced that results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline ("DFD-29" or commercially known as "Emrosi™) on skin, gastrointestinal ("GI") and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology, a leading peer-reviewed publication in clinical dermatology.

Lexicon Pharmaceuticals, Inc announced the publication of preclinical data validating Acyl-CoA Synthetase 5 (ACSL5) as a target for obesity and chronic weight management.

Pfizer Inc. announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA® (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction, in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

PTC Therapeutics Canada ULC announced that Health Canada has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU).

Kazia Therapeutics Limited announced new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) providing compelling mechanistic and early clinical evidence supporting the activity of paxalisib, the Company's brain-penetrant dual PI3K/mTOR inhibitor, across both HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC).

NuCana plc presented the latest clinical data at the annual European Society for Medical Oncology ("ESMO") Immuno-Oncology Congress, December 10-12, 2025, in London.

Barinthus Biotherapeutics plc announced an update on its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease.

BriaCell Therapeutics Corp a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, presents positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

Sagimet Biosciences Inc. announced that Ascletis Pharma Inc. issued a December 10 statement that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne.

MediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries.

IDEAYA Biosciences, Inc announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes.

GSK plc announced that its B7-H3-targeted antibody-drug conjugate GSK’227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of small-cell lung cancer (SCLC).

IGC Pharma, Inc. announced it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.

Akari Therapeutics, Plc announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and most treatment-resistant forms of cancer.

PDS Biotechnology announced that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims.

Moleculin Biotech, Inc., today provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML).

Atossa Therapeutics, Inc announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,479,790 B2, titled, "Methods for Making and Using Endoxifen."

Celldex announced the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment.

Lucid Diagnostics subsidiary of PAVmed Inc. announced new data from the largest reported real-world experience of non-endoscopic esophageal precancer (Barrett's esophagus or BE) detection, which evaluated its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device.

Coya Therapeutics, Inc. announced that dosing of ALS patients in the Company's ALSTARS Trial of COYA 302 has commenced.

Ensysce Biosciences, announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical trial of PF614, its lead product candidate.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.

Johnson & Johnson announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as early as second line for patients with relapsed/refractory multiple myeloma (RRMM).

OS Therapies Inc. announced that it held a successful pre-Marketing Authorisation Application (MAA) with the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) regarding the Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program').

Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, versus bendamustine plus rituximab (BR), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.

BriaCell Therapeutics Corp. is pleased to announce its Phase 3 clinical study has screened over 230 and enrolled over 160 patients. BriaCell anticipates reporting topline data as early as 1H2026.

Castle Biosciences, Inc. nnounced the publication of an independent expert consensus paper titled "31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel," which endorses the Company's DecisionDx-Melanoma test.

Opus Genetics announced that the Independent Data Monitoring Committee (IDMC) issued a positive recommendation to continue as planned in the Company's Phase 1/2 BEST1 clinical trial (BIRD-1), which is a multi-center, adaptive, open-label, dose-exploring study evaluating OPGx-BEST1 in participants with Best disease.

AstraZenca announced that The first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab.

Pulse Biosciences, Inc. announced a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company's nPulse™ Vybrance™ Percutaneous Electrode System for treatment of thyroid cancers.

BioNTech SE and announced the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer ("TNBC") irrespective of PD-L1 expression levels. Bristol Myers Squibb Company

Senti Biosciences announced new data from its ongoing multinational, multicenter clinical trial of SENTI-202, a first-in-class CD33/FLT3 targeting Logic Gated CAR NK cell therapy being studied in patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).

Ascentage Pharma Group International announced that it presented four year follow-up data from its randomized controlled, registrational Phase II study of Olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP), in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, Florida.

Eisai Co., and Biogen Inc. announced today that anti-Aβ protofibril* antibody "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab), has been included in the "Commercial Insurance Innovative Drug List" (Chinese: 商业健康保险创新药品目录), recently introduced by the National Healthcare Security Administration (NHSA) of China.

Exicure, Inc. announced positive results from its completed Phase 2 trial evaluating burixafor (GPC-100) in combination with propranolol and granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic progenitor cells (HPCs) in patients with multiple myeloma undergoing autologous hematopoietic cell transplantation (AHCT).

Genmab A/S announced new and updated data from three arms of the ongoing Phase 1b/2 EPCORE® CLL-1 trial (NCT04623541) evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination for the treatment of patients with Richter transformation (RT), a rare complication in which chronic lymphocytic leukemia (CLL) evolves into an aggressive lymphoma, most often diffuse large B-cell lymphoma (DLBCL).

Assembly Biosciences, Inc announced positive interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitors in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes.

Cardiff Oncology, Inc. announced that clinical data from an investigator-sponsored trial with onvansertib in chronic myelomonocytic leukemia (CMML) will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting.

Terns Pharmaceuticals, announced that updated and expanded data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in patients with previously treated chronic myeloid leukemia (CML) are being presented today at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 6-9, 2025 in Orlando, FL.

Actinium Pharmaceuticals a company developing targeted alpha radiotherapies, is advancing its solid-tumor program with a Phase 1 clinical trial in South Africa targeting B7-H3. This study represents one of the earliest clinical explorations of the company’s ATNM-400 platform, which uses the alpha-emitting isotope Actinium-225 (Ac-225) to deliver highly potent radiation directly to cancer cells.

GRI Bio, Inc. has received topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

Cullinan Therapeutics today shared updated clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Corvus Pharmaceuticals, Inc. announced the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place December 6-9, 2025 in Orlando, FL.

Kura Oncology, Inc. announced new data demonstrating a favorable safety profile and encouraging antileukemic activity for KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine (ven/aza) for the treatment of acute myeloid leukemia (AML) harboring NPM1 mutations (NPM1-m) or KMT2A rearrangements (KMT2A-r).

Ernexa Therapeutics announced the presentation of new preclinical data on its lead cell therapy candidate, ERNA-101, at the American Society of Hematology (ASH) Annual Meeting.

Polyrizon Ltd. announces that it has successfully completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its PL-14 Allergy Blocker product, a novel nasal spray designed to provide protective intranasal barrier functionality.

Geron Corporation announced new data presented at the 67th American Society of Hematology (ASH) 2025 Annual Meeting being held in Orlando, FL.

SAB Biotherapeutics, Inc announced that the Company will give several oral presentations at the 2nd Asian Conference on Innovative Therapies for Diabetes Management (ATTD-Asia) being held December 9-11, 2025, in Singapore..

Nurix Therapeutics, Inc. today presented new clinical data from patients with relapsed or refractory Waldenström macroglobulinemia (WM) treated in the Phase 1 clinical trial of its Bruton's tyrosine kinase (BTK) degrader bexobrutideg (NX-5948).

Fate Therapeutics, Inc. presented updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus (SLE) and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.

Autolus Therapeutics plc announces presentation of preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients, as well as further insights from the registrational FELIX study in adult r/r B-ALL, at the American Society of Hematology (ASH) Annual Meeting.

Coherus Oncology, announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi) plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

Vyome Holdings, Inc. announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds ("MFW").

Cogent Biosciences, Inc. announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response.

Recursion announced positive Phase 1b/2 data from the ongoing TUPELO trial of REC-4881, an investigational allosteric MEK1/2 inhibitor for familial adenomatous polyposis (FAP).

BiomX Inc. announced its discontinuation of the ongoing Phase 2b clinical trial of nebulized phage therapy BX004 in patients with CF associated with chronic Pseudomonas aeruginosa infections.

Abeona Therapeutics Inc announced the first commercial patient treatment with FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, autologous gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Wave Life Sciences Ltd. announced positive interim data from the lowest therapeutic cohort of the ongoing first-in-human INLIGHT trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave's proprietary SpiNA design, for the treatment of obesity.

Ocular Therapeutix, Inc. announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA's Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026.

Merck announced that the province of Saskatchewan has added CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine, to its publicly funded adult immunization program.

Zai Lab Limited announced the dosing of the first participant in a global Phase 1/1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503, a potential first-in-class IL-13/IL-31R bispecific antibody for the treatment of atopic dermatitis (AD).

Kymera Therapeutics, announced positive clinical results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its first-in-class, oral STAT6 degrader medicine.

Agios Pharmaceuticals, announced that The Prescription Drug User Fee Act (PDUFA) goal date issued by the FDA was December 7, 2025.

Agios Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the supplemental New Drug Application (sNDA) for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia and that the sNDA remains under active review.

Vaxcyte, Inc. announced that the first participants were dosed in the OPUS (OPA-based Pivotal U.S. Study) Phase 3 pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults.

Dyne Therapeutics, Inc. announced positive topline results from the Registrational Expansion Cohort (REC) of its Phase 1/2 DELIVER trial evaluating zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

MediciNova announced an update and the patients' basic characteristics data from its Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS), known as the COMBAT-ALS study.

Greenwich LifeSciences, announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01.

PureTech Health plc announced the successful completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF).

TScan Therapeutics, Inc. announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).

Protagonist Therapeutics, Inc and Takeda announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

Ascentage Pharma Group International announced that it presented the latest results from a Phase Ib/II study of Lisaftoclax (APG-2575), a key investigational drug candidate in the Company's pipeline, in combination with azacitidine (AZA) in patients with newly diagnosed or prior venetoclax–exposed myeloid malignancies in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, Florida.

Johnson & Johnson announced updated results from the Phase 3 CARTITUDE-4 study supporting durable treatment-free remissions as early as second line treatment with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel).

Immix Biopharma, Inc. announced positive phase 2 NXC-201 results in an oral presentation at ASH 2025 presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center.

Fulcrum Therapeutics, Inc. reported positive initial results from the ongoing 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD).

BeOne Medicines Ltd announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies.

SELLAS Life Sciences Group, Inc. announced that clinical data from its ongoing Phase 2 study of SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented today at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6 – 9, 2025, in Orlando, Florida.

TScan Therapeutics, Inc. announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).

Kite, a Gilead Company presented a new analysis today demonstrating that second-line Yescarta® (axicabtagene ciloleucel) therapy offers consistent benefits in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL), even among those ineligible for the previous standard of care, high-dose chemotherapy followed by an autologous stem cell transplant (ASCT).

ALX Oncology Holdings Inc announced that positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept, in combination with standard-of-care rituximab and lenalidomide, for patients with indolent B-cell non-Hodgkin lymphoma (iNHL) is being presented Sunday, December 7 during a poster presentation at the American Society of Hematology (ASH) Annual Meeting 2025 in Orlando, Florida.

Regeneron Pharmaceuticals, Inc announced encouraging data from the Phase 1/2 LINKER-MM4 trial evaluating Lynozyfic™ (linvoseltamab) in adults with newly diagnosed multiple myeloma (NDMM) who were transplant eligible or ineligible were shared in an oral presentation at the American Society of Hematology (ASH) Annual Meeting.

Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-314 clinical trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve.

Lyell Immunopharma, Inc announced new clinical and translational data from the ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients with large B-cell lymphoma (LBCL), which were presented today in two oral presentations at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

Wave Life Sciences Ltd. will announce interim data from the ongoing Phase 1 INLIGHT clinical trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave's proprietary SpiNA design, for the treatment of obesity on Monday, December 8, 2025.

Rigel Pharmaceuticals, Inc announced updated data from its ongoing Phase 1b study evaluating R2891, an oral prodrug of R835, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS).

Prime Medicine, Inc announced the publication of Phase 1/2 clinical data with PM359, the Company's investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease (CGD) in the New England Journal of Medicine (NEJM).

ALX Oncology Holdings Inc announced that positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept, in combination with standard-of-care rituximab and lenalidomide, for patients with indolent B-cell non-Hodgkin lymphoma (iNHL) is being presented Sunday, December 7 during a poster presentation at the American Society of Hematology (ASH) Annual Meeting 2025 in Orlando, Florida.

Genmab A/S announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

Ad hoc announcement pursuant to Art. 53 LR Molecular Partners announced it will present updated data from a Phase 1/2a trial of the multispecific T-cell engager MP0533 in patients with acute myeloid leukemia (AML) in a poster at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.

Evaxion A/S announces new data demonstrating that its AML vaccine candidate, EVX-04, triggers strong specific T-cell responses and effectively prevents tumor growth in preclinical models.

Ascentage Pharma Group International Inc. announced that it has presented an oral report featuring the latest results from a registrational Phase II study conducted in China of Lisaftoclax (APG-2575), a key drug candidate in the Company‘s pipeline, as a monotherapy in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed Bruton's tyrosine kinase inhibitors (BTKis), at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, FL.

Cogent Biosciences, Inc. announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).

Genmab A/S announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination with other standard of care treatments in adult patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Nurix Therapeutics, Inc. announced new clinical data from the Company's ongoing Phase 1a/1b NX-5948-301 study of bexobrutideg (NX-5948) in patients with relapsed or refractory B-cell malignancies.

Adaptive Biotechnologies announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6–9, 2025, in Orlando.

Arvinas, Inc. announced preclinical data for ARV-393, a PROTAC BCL6 degrader, in combination with glofitamab, a CD20×CD3 bispecific antibody, presented in a poster at the 67th American Society of Hematology (ASH®) Annual Meeting and Exposition, held December 6–9, 2025, in Orlando, Florida.

Beam Therapeutics Inc. announced new safety and efficacy data from its BEACON Phase 1/2 clinical trial of ristoglogene autogetemcel (risto-cel), formerly known as BEAM-101, an investigational genetically modified ex vivo base editing cell therapy, in patients with sickle cell disease (SCD) with severe vaso-occlusive crises (VOCs).

Disc Medicine, Inc. , today presented positive initial data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASH Annual Meeting in Orlando, FL.

Bicara Therapeutics Inc. presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Vertex Pharmaceuticals Incorporated announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).

Pfizer Inc presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors.

Kymera Therapeutics, announce results from the BroADen Phase 1b clinical trial evaluating KT-621, its oral STAT6 degrader, in patients with moderate to severe atopic dermatitis (AD) on Monday, December 8, 2025.

PureTech Health plc announced initial topline results from the Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Amylyx Pharmaceuticals, Inc. announced the presentation of early safety and tolerability data from its Phase 1 LUMINA trial of AMX0114 and results from ongoing work characterizing biomarkers of AMX0114 target engagement at the 36th International Symposium on ALS/MND (MNDA) held from December 5-7 in San Diego, California.

ORIC Pharmaceuticals, Inc. announced data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025.

Stoke Therapeutics, Inc and Biogen Inc. announced data presentations that further support the potential of zorevunersen, an investigational antisense oligonucleotide, as a disease-modifying medicine for Dravet syndrome.

Rapport Therapeutics, Inc announced new data and post hoc analysis on clinical and patient reported benefits of RAP-219 in drug-resistant focal onset seizures (FOS), alongside topline efficacy and safety data from its recently reported Phase 2a FOS trial.

Lexicon Pharmaceuticals, Inc announced clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin will be presented at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025). The conference is being held December 8-10, 2025, at the Mayflower Hotel in Washington, D.C.

CG Oncology, Inc. announced topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A which demonstrated promising efficacy, safety and tolerability.

Amneal Pharmaceuticals, Inc announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson's Study Group (PSG) Annual Meeting.

OS Therapies Inc. announced the United States Food & Drug Administration (FDA) granted the Company waiver of the application fee for BLA 125867 for OST-HER2.

IDEAYA Biosciences, Inc. announced that it has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC).

Biofrontera Inc. announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas).

BioAge Labs, Inc. announced positive interim data from the ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial evaluating BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for treatment of patients with cardiovascular risk factors.

Senti Biosciences, Inc. announced it will host a conference call and webcast to discuss updated clinical results from SENTI-202 being presented at the ASH Annual Meeting on Tuesday, December 9, 2025 at 8:00 AM ET.

Galmed Pharmaceuticals Ltd. announced today the grant of a new Use Patent related to its lead compound, Aramchol.

ENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.

Absci Corporation announced that the first healthy volunteers have been dosed in the Phase 1/2a HEADLINE study evaluating ABS-201, an investigational anti-prolactin receptor (PRLR) antibody engineered with Absci's generative AI platform.

Atossa Therapeutics, Inc. announced the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen.

ENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.

Estrella Immunopharma, Inc. announced that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial.

Absci Corporation announced that the first healthy volunteers have been dosed in the Phase 1/2a HEADLINE study evaluating ABS-201, an investigational anti-prolactin receptor (PRLR) antibody engineered with Absci's generative AI platform.

Pliant Therapeutics, Inc. announced interim data from its Phase 1 dose escalation clinical trial evaluating PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

Pelthos Therapeutics Inc. announced it has signed its first commercial agreement to expand patient access for ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older ("ZELSUVMI").

uniQure N.V. announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntington's disease (HD).

AstraZeneca advances its ambition to redefine hematology care with new data from its diverse pipeline and portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, 2025.

Insulet Corporation announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System.

Perspective Therapeutics, announced that updated data on the Company's [212Pb]VMT-α-NET program have been accepted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) Congress 2026 taking place from January 8 to 10, 2026 in San Francisco, CA as detailed below.

Purple Biotech Ltd. announced that it will present new preclinical data from its CAPTN-3 platform of conditionally activated tri-specific antibodies at the upcoming European Society of Medical Oncology Immuno-Oncology (ESMO-IO) 2025 Annual Congress being held from December 10–12, 2025, in London, United Kingdom.

Axogen, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Biologics License Application ("BLA") for AVANCE® (acellular nerve allograft-arwx).

Eisai Co., and Biogen Inc. announced that the latest findings on time savings with continued treatment with humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab (generic name, U.S. brand name LEQEMBI®) were presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference.

Apellis Pharmaceuticals, announced that The New England Journal of Medicine (NEJM) published positive results from the Phase 3 VALIANT study investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases.

Medtronic announced the U.S. Food and Drug Administration (FDA) has cleared the Hugo™ robotic-assisted surgery (RAS) system for use in urologic surgical procedures.

TScan Therapeutics, Inc. announced the Company will host a virtual key opinion leader (KOL) event to discuss updated data from the ALLOHA™ Phase 1 trial being presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition and the future market opportunity for its heme program.

ORIC Pharmaceuticals, Inc. announced two late-breaking oral presentations highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025 taking place December 5-7, 2025 in Singapore.

Eli Lilly And Co announced that the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.

PolyPid Ltd. announced that it has received a formal pre-New Drug Application ("NDA") meeting minutes from the U.S. Food and Drug Administration ("FDA") supporting the NDA submission of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries.

Lantern Pharma Inc announced additional details and clinical insights from its completed Phase 1a dose-escalation study of LP-184 as well as highlights from its recent webinar.

Incannex Healthcare Inc. announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company's oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA).

Sutro Biopharma, Inc nnounced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors.

Crinetics Pharmaceuticals, Inc. announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors.

Nuvation Bio Inc announced the publication of positive results from a Phase 2 study of safusidenib, a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1, in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas.

Nexalin Technology, Inc. announced the successful completion of a substantive Q-Submission ("Q-Sub") meeting with the U.S. Food and Drug Administration ("FDA") regarding its Gen-2 SYNC™ neurostimulation console for the treatment of Alzheimer's disease.

Protara Therapeutics, Inc. announced updated interim data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC).

ADC Therapeutics SA announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

Relmada Therapeutics, announced that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025).

Capricor Therapeutics announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel, the Company's investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD).

Black Diamond Therapeutics, Inc. announced topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs) and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma (ND GBM).

NRx Pharmaceuticals, announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include the use of NRX-101 in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.

Bristol Myers Squibb announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites.

Pharvaris announced RAPIDe-3 pivotal data confirming the potential of deucrictibant's differentiated profile for the on-demand treatment of HAE attacks.

Greenwich LifeSciences, Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date

Eisai Co., Ltd. and Biogen Inc announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference.

Jazz Pharmaceuticals plc announced two abstracts featuring key data for Ziihera® (zanidatamab-hrii) have been accepted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) from January 8-10, 2026, in San Francisco.

Black Diamond Therapeutics will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.

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 locally recurrent prostate cancer using the Company's Alpha DaRT technology.

Jaguar Health,nnounced that its Italian subsidiary, Napo Therapeutics S.p.A., has submitted a request to the European Medicines Agency (EMA) to have the EMA's Committee for Veterinary Medicinal Products (CVMP) provide scientific advice regarding the company's plan to pursue approval of Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs based on data from a study Jaguar completed in 200 dogs in 2017

Biofrontera Inc. announced the submission of an sNDA to the FDA, seeking approval of Ameluz®-PDT for the treatment of sBCC.

NRx Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has received the Company's Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation.

Fulcrum Therapeutics, to review new clinical data from the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD).

PDS Biotechnology announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.

SeaStar Medical Holding announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients.

Pacira BioSciences, Inc. announced results from a randomized 30-patient pilot study evaluating iovera° cryoneurolysis versus radiofrequency ablation (RFA) for chronic low back pain (CLBP).

Harmony Biosciences Holdings, Inc announced that it will highlight new open-label extension data from the company's investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA.

Sangamo Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.

Insilico Medicineand Atossa Therapeutics announce the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM).

Chemomab Therapeutics announced that the results of its Phase 2 SPRING trial assessing nebokitug in patients with primary sclerosing cholangitis (PSC) were published in the current issue of the American Journal of Gastroenterology.1

Acumen Pharmaceuticals, announced new research at the 18th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place December 1-4, 2025, in San Diego and online. Results from a collaborative study with JCR Pharmaceuticals demonstrated improved delivery of AβO-targeting monoclonal antibodies to the central nervous system, including sabirnetug (ACU193), through the blood-brain barrier using the transferrin receptor (TfR) pathway, which is being developed to potentially increase and broaden brain distribution and maximize the efficacy-to-safety ratio.

Immutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025.

Amneal Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the Company's albuterol sulfate inhalation aerosol (90 mcg per actuation).

Silexion Therapeutics Corp. announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of the Company's planned Phase 2/3 clinical trial for SIL204, the Company's lead product candidate for locally advanced pancreatic cancer.

Clearmind Medicine Inc. announced another key milestone in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD): the first participant has been enrolled and dosed with CMND-100, its proprietary MEAI-based oral drug candidate, at Hadassah-University Medical Center in Jerusalem, Israel.

BriaCell Therapeutics Corp will be presenting positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

AstraZeneca's New Drug Application (NDA) for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration (FDA) in the US for the treatment of adult patients with hard-to-control (uncontrolled or treatment resistant) hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure.

AstraZeneca announced that The Prescription Drug User Fee Act (PDUFA) date is anticipated during the second quarter of 2026 following use of a Priority Review voucher.

enGene Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC).

Arrowhead Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL).

Jasper Therapeutics, reported positive preliminary clinical data from Jasper's ETESIAN Phase 1b study of subcutaneous briquilimab in adult participants with allergic asthma.

Fennec Pharmaceuticals Inc. announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan.

Ionis Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare, progressive and often fatal neurological condition.

Fractyl Health, Inc. announced positive 6-month results from its open-label REVEAL-1 Cohort.

CervoMed Inc has shared new data from the Phase 2b RewinD-LB trial demonstrating neflamapimod treatment led to a significant reduction in the widely used neurodegeneration biomarker plasma GFAP and an increase in A42/40 ratio, an inverse marker of neuroinflammation and amyloidogenesis.

ANI Pharmaceuticals, Inc. announced that it has established The FutureVision Advisory Council to help guide the strategic advancement of its ophthalmology and retina franchise within the Company's Rare Disease business.

Protara Therapeutics, Inc. announced that it will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC).

Janux Therapeutics, Inc. announced positive updated interim data for its JANX007, a PSMA-directed TRACTr, Phase 1 clinical program in patients with mCRPC. Janux will host a virtual event on Monday, December 1, 2025, at 4:30 PM ET.

Citius Oncology, Inc. announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl).

Longeveron Inc announced that its submission entitled "Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study" is being presented in a poster presentation at the 18th Clinical Trials on Alzheimer's Disease Conference (CTAD 2025) being held December 1-4, 2025 in San Diego, CA.

Clearmind Medicine Inc. announced three transformative milestones in its FDA-approved Phase I/IIa clinical trial for CMND-100—the Company's proprietary, non-hallucinogenic, MEAI-based oral therapy targeting Alcohol Use Disorder (AUD).

Actinium Pharmaceuticals, Inc. announced compelling preclinical data for ATNM-400, a first-in-class Actinium-225 (AC-225) antibody radioconjugate, in hormone receptor positive (HR+), HER2 positive (HER2+) and triple-negative breast cancer (TNBC) that will be presented at the San Antonio Breast Cancer Symposium (SABCS) being held December 10‑14, 2025 in San Antonio, Texas.

Recursion announced today that it will present a new clinical readout from the ongoing TUPELO Phase 1b/2 trial of REC-4881 in FAP at an upcoming company webinar.

LENZ Therapeutics, Inc. announced that Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZTM, for the treatment of presbyopia in adults in South Korea.

MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow™ Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX® (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD).

INmune Bio, Inc. announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer's disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA.

Daré Bioscience, Inc. announced that all rights to Ovaprene®, the company's first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as part of a strategic prioritization.

Solid Biosciences Inc. announced that it received Rare Pediatric Disease designation from the U.S. Food and Drug Administration (FDA) for SGT-212, the Company's investigational gene therapy for Friedreich's ataxia (FA).

Plus Therapeutics, Inc announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX.

Cardiol Therapeutics Inc. announced new and comprehensive data from ARCHER, a randomized double-blind, placebo-controlled, multi-center Phase II clinical trial of CardiolRx™ in patients with acute myocarditis.

Biogen Inc. and Stoke Tannounced data presentations from studies of zorevunersen at the 2025 American Epilepsy Society (AES) Annual Meeting, taking place December 5-9 in Atlanta, Georgia.herapeutics, Inc.

Cardiol Therapeutics Inc. announced new and comprehensive data from ARCHER, a randomized double-blind, placebo-controlled, multi-center Phase II clinical trial of CardiolRx™ in patients with acute myocarditis.

Ionis Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olezarsen as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (sHTG) (TG greater than or equal to 500 mg/dL).

Bicara Therapeutics Inc. announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Nurix Therapeutics, Inc. announced that the company will host a live webcast on Monday, December 8, 2025, at 8:15 p.m. ET, to review new and updated clinical data from the ongoing Phase 1a/1b clinical trial of its Bruton's tyrosine kinase (BTK) degrader program, bexobrutideg (NX-5948), and provide a corporate update.

Cullinan Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

Regeneron Pharmaceuticals, Inc and Tessera Therapeutics, Inc.,announced a global collaboration to develop and commercialize TSRA-196, Tessera's lead investigational in vivo Gene Writing program for the treatment of alpha-1 antitrypsin deficiency (AATD), an inherited monogenic disease that can affect the lungs, liver, or both organs, and currently impacts approximately 200,000 people in the U.S. and Europe.

Merck announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer's Disease (CTAD) 2025 in San Diego, California from Dec. 1-4.

IDEAYA Biosciences, Inc. announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC).

Belite Bio, Inc announced topline results from the global Phase 3 "DRAGON" trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1).