FDA Calendar

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

IGC Pharma, Inc announced the expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, an investigational drug candidate for treating agitation in patients with Alzheimer's disease. The Company has added a clinical site at the Lynn Health Science Institute (LHSI) in Oklahoma City, Oklahoma.

Amgen announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.'

PDS Biotechnology announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer ("1L R/M HNSCC").

Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025.

Catalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. ("SERB") have entered into a Settlement Agreement ("Agreement") with Lupin Ltd and Lupin Pharmaceuticals, Inc. (collectively, "Lupin").

Amarin Corporation plc announced upcoming presentations at the European Society of Cardiology (ESC) Congress 2025, August 29th-September 1st, in Madrid, Spain, where new data will further illuminate the multifaceted cardioprotective effects of icosapent ethyl (IPE).

Natera, Inc announced that it will present new data at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, taking place September 6 - 9 in Barcelona, Spain.

Coya Therapeutics, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302.

Evolus, Inc announced positive topline results from a U.S. pivotal study of Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.

Artelo Biosciences, Inc. announced encouraging results from its preliminary food effect evaluation with ART26.12.

BridgeBio Pharma, Inc. announced today that one rapid-fire oral presentation on additional open-label extension data from ATTRibute-CM and two ePosters with ATTRibute-CM data at Month 30 will be shared at the European Society of Cardiology (ESC) Congress 2025, taking place in Madrid, Spain from August 29 - September 1, 2025.

Cytokinetics announced five presentations related to aficamten at the European Society of Cardiology Congress 2025 taking place in Madrid, Spain from August 29, 2025 – September 1, 2025 including a Hot Line presentation of the primary results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) and a Late Breaking Clinical Science presentation relating to the incidence and impact of atrial fibrillation across three clinical trials of aficamten in obstructive hypertrophic cardiomyopathy (HCM).

Alkermes plc announced plans to present detailed results from its Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at World Sleep Congress, taking place Sept. 5-10, 2025 in Singapore, and in an investor webcast presentation hosted by the company.

Sionna Therapeutics, announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector.

Castle Biosciences, announced the publication of two new studies related to its DecisionDx-SCC test, adding to its validated uses for patients with high-risk cutaneous squamous cell carcinoma (SCC).1,2 DecisionDx-SCC is a gene expression profile test (40-GEP) designed to use a patient's tumor biology to predict individual risk of metastasis as well as response to adjuvant radiation therapy (ART).

Protagonist Therapeutic announced today that rusfertide, a potential first-in-class hepcidin-mimetic peptide, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with polycythemia vera (PV).

Xeris Biopharma Holdings, Inc announced the U.S Patent and Trademark Office has issued patent number 12,377,096 to the Company for Recorlev® (levoketoconazole) and that this patent is now listed in the publication, "Approved Drug Products with Therapeutics Equivalence Evaluations," commonly known as the "Orange Book."

Bristol Myers Squibb announced the presentation of new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 29 – September 1, 2025, in Madrid, Spain.

Merck announced that new clinical trial and outcomes research data will be presented at the European Society of Cardiology Congress (ESC) 2025 in Madrid, Spain from August 29 – September 1.

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder.

Eisai Co., and Biogen Inc. announced today that the anti-amyloid beta (Aβ) monoclonal antibody "LEQEMBI®" has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025.

argenx SE announced positive topline data from the pivotal ADAPT SERON study of VYVGART® (IV: efgartigimod alfa-fcab).

Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant, for individuals aged six months and older.

Citius Oncology, Inc the oncology-focused subsidiary of Citius Pharmaceuticals, Inc announced that it has deployed an innovative AI platform to support its commercial team with advanced data analytics and insights ahead of the anticipated launch of LYMPHIR™, a novel therapy for cutaneous T-cell lymphoma (CTCL).

Shattuck Labs, Inc announced that the Company's Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) for SL-325 for the treatment of inflammatory bowel disease is in effect. SL-325, a potentially first-in-class DR3 blocking antibody, is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody, demonstrated high-affinity binding to human DR3 and potent inhibition of TL1A binding to DR3 in preclinical studies, and a favorable safety profile in non-human primate studies.

Jaguar Health, Inc announced it is participating in the 2025 Animal Health Summit in support of the company's goal of securing a collaboration to expand the indication of Canalevia (crofelemer delayed-release tablets) from treatment of chemotherapy-induced diarrhea (CID) in dogs to treatment of general diarrhea in dogs..

Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH).

AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).1

Septerna, announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) being developed for the treatment of chronic spontaneous urticaria (CSU) and other mast cell-driven diseases.

Tyra Biosciences, Inc. announced today that the first child has been dosed in BEACH301, a Phase 2 clinical study evaluating the safety and efficacy of dabogratinib in children with achondroplasia, the most common form of dwarfism.

Dynavax Technologies announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years.

Protagenic Therapeutics, Inc. announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114.

Evoke Pharma, Inc. announced that U.S. Patent No. 12,377,064 covering the use of GIMOTI® (metoclopramide) nasal spray in patients with moderate to severe symptoms of gastroparesis, has been listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the "Orange Book".

PureTech Health plc demonstrated its growing leadership in idiopathic pulmonary fibrosis (IPF) at the 2025 IPF Summit this week in Boston. The Company highlighted the strength of its Phase 2b ELEVATE IPF trial data supporting the advancement of deupirfenidone (LYT-100) into Phase 3 by its newest Founded Entity, Celea Therapeutics ("Celea"), and shared new patient preference data and insights shaped by deep engagement across the IPF treatment ecosystem.

Alvotech announced that the European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), in a pre-filled syringe and vial.

Rhythm Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity.

Savara Inc. announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM.

Tharimmune, Inc. announced positive results from a recent pharmacokinetic (PK) simulation analysis of its lead clinical asset, TH104, a buccal film formulation of nalmefene.

Evolus, Inc. announced that it has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.

Agilent Technologies Inc. announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb's Opdivo® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy® (ipilimumab).

Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease.

Novocure announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer.

Enanta Pharmaceuticals, Inc announced today that it has filed suit in the Unified Patent Court (UPC) of the European Union against Pfizer Inc. and certain of its subsidiaries (action number 35071/2025), seeking a determination of liability for use and infringement of European Patent No. EP 4 051 265 (the '265 Patent) in the manufacture, use and sale of Pfizer's COVID-19 antiviral, Paxlovid™ (nirmatrelvir tablets; ritonavir tablets).

CytoSorbents Corporation updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authorization of DrugSorb™-ATR.

Celldex Therapeutics, Inc today reported topline results from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

Madrigal Pharmaceuticals, Inc announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

HUTCHMED (China) Limited announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer ("NSCLC") patients whose tumors harbor epidermal growth factor receptor ("EGFR") mutation and MET overexpression. The last patient was enrolled on August 18, 2025.

Jaguar Health, Inc. announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company's ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder.

60 Degrees Pharmaceuticals, announced today it has signed a clinical trial agreement with the Icahn School of Medicine at Mount Sinai in New York City as the central site for a Phase II clinical study of tafenoquine in treating chronic babesiosis.

āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of bone and connective tissue disorders, today announced an exclusive licensing agreement with Mereo BioPharma for vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare, debilitating bone disorder with no approved therapies.

ImmunityBio, Inc announced the opening of a new Phase 2 study to assess the BioShield™ platform, anchored by ANKTIVA® (nogapendekin alfa inbakicept-pmln), in patients with long COVID.

Delcath Systems, Inc. announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC).

MIRA Pharmaceuticals, Inc. announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2.

BiomX Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase 2b trial of BX004 for the treatment of patients with cystic fibrosis (CF).

Silo Pharma, Inc. announced positive bioanalytical and safety/toxicology results for its U.S. Food and Drug Administration (FDA)-requested 7-day large animal safety study of its lead asset SPC-15.

Rein Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Company to initiate its Phase 2 "RENEW" clinical trial of LTI-03, the Company's lead drug candidate for idiopathic pulmonary fibrosis (IPF).

ALX Oncology Holdings Inc announced that the first patient has been dosed in the Company's Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors.

Altimmune, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD).

Viking Therapeutics, Inc. announced positive top-line results from the company's Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.

Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa.

BioXcel Therapeutics announced completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia. Topline results from the study are expected in August.

REGENXBIO Inc. announced that the U.S. Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

Invivyd, Inc. announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA® (pemivibart) against the currently dominant and growing XFG variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, XFG did not generate any meaningful change to the in vitro neutralization activity of pemivibart or VYD2311, the company's next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitopes targeted by pemivibart and VYD2311 remain structurally intact.

Iovance Biotherapeutics, announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy.

Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry.

Capricor Therapeutics announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome-based vaccine.

Biodexa Pharmaceuticals PLC is pleased to announce the enrolment of the first two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer.

NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Administration ("FDA") clearance to market its OneRF® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and Dr. Reddy's Laboratories Ltd. announced the launch of Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA).

Savara Inc announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, September 27 – October 1, Amsterdam, The Netherlands.

Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1 (BEST1)-related IRD.

Ultragenyx Pharmaceutical announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for DTX401 AAV gene therapy as a treatment for Glycogen Storage Disease Type Ia (GSDIa).

Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis

Soligenix, Inc. announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet's Disease" following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease.

Plus Therapeutics, Inc. announces positive data from the ReSPECT-LM Phase 1 single dose escalation trial presented at the podium at the SNO/ASCO CNS Metastases Conference in Baltimore, MD.

Unicycive Therapeutics, announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.

Vanda Pharmaceuticals Inc. announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. FDA, case no. 24-1049).

Labcorp announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients.

BioXcel Therapeutics, announced that it has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration (FDA).

Daiichi Sankyo and Merck announced that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

Traws Pharma, Inc. announced receipt from the Human Research Ethics Committee (HREC) of approval to proceed with a Phase 2 study to evaluate ratutrelvir, a ritonavir-free treatment in newly diagnosed COVID subjects.

SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

Natera, Inc. announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The trial is sponsored by Genentech, a member of the Roche Group.

Ascentage Pharma announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).

Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy® (semaglutide) injection 2.4 mg, making it the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) FDA-approved to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity.1

Tonix Pharmaceuticals Holding Corp announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults.

Pfizer Inc announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with sickle cell disease (SCD).

BioAge Labs, Inc. announced that the first participant has been dosed in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for the treatment of obesity.

Precigen, Inc. announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP.

Akero Therapeutics, Inc. announced publication of 96-week results from the Phase 2b HARMONY trial in The Lancet.

Invivyd, Inc. announced it has received and is aligned with advice from the U.S. Food and Drug Administration (FDA) on a compact and, therefore, rapid pathway to potential Biologics License Application (BLA) approval for Invivyd's novel monoclonal antibody (mAb) candidate VYD2311, for the prevention of COVID-19.

Tiziana Life Sciences, Ltd. announced that the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients living with Multiple System Atrophy (MSA) at Brigham and Women's Hospital in Boston, Massachusetts.

Enlivex Therapeutics Ltd. announced it will host a webinar on Monday, August 18, 2025, at 8:00 AM Eastern Time to present and discuss 3-month topline results from the Phase IIa stage of its Phase I/IIa ENX-CL-05-001 trial, a double-blind, randomized, placebo-controlled multi-centered study.

Scholar Rock announced that positive study results from the pivotal Phase 3 SAPPHIRE trial (NCT05156320) were published in the peer-reviewed journal The Lancet Neurology.

Beam Therapeutics Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101, an investigational genetically modified cell therapy for the treatment of sickle cell disease (SCD).

Athira Pharma, Inc. presented results from its Phase 1 clinical trial of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference in Dallas, Texas.

Summit Therapeutics Inc. announced that data from the Phase III HARMONi trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented as part of the Presidential Symposium at the International Association for the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona on Sunday, September 7, 2025, at 8:15am CET (2:15am ET).

Verastem Oncology announced positive, updated safety and efficacy data and late-breaking presentation details of partner GenFleet Therapeutics' Phase 1/2 study in China of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, known as VS-7375 outside of China, in advanced non-small cell lung cancer patients with a KRAS G12D mutation.

Nuvalent, Inc. announced that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025). The conference is hosted by the International Association for the Study of Lung Cancer and is being held September 6-9, 2025, in Barcelona, Spain.

PureTech Health plc announced that its candidate VE202 did not meet the primary endpoint in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC).

Creative Medical Technology announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.

MediWound Ltd. announced the publication of "The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial", in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair.

Mainz Biomed N.V announced that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.

ImmunityBio announced early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural killer cell therapy.

Vor Bio announced that its collaborator, RemeGen Co., Ltd achieved the primary endpoint in a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren's disease.

Aligos Therapeutics, Inc. announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV) infection.

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. announced that two of the company's infectious disease therapies, ZEVTERA® (ceftobiprole medocaril sodium for injection) and XACDURO® (sulbactam/durlobactam for injection) have been nominated for the prestigious 2025 Prix Galien USA Award, "Best Pharmaceutical Product."

CytomX Therapeutics, Inc provided an update on the CX-2051 Phase 1 study to address certain recent social media posts.

Tharimmune, announced a significant expansion of its intellectual property portfolio for TH-104, its novel transmucosal film.

Aptevo Therapeutics Inc. today reinforced the strategic importance of its preclinical asset APVO442-an investigational CD3-engaging bispecific antibody designed to treat prostate cancer.

Merck announced today that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1), as determined by a validated test, as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy.

Ocugen, Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).

Greenwich LifeSciences, Inc. announced the addition of clinical sites in Romania.

Cognition Therapeutics, announced that it has received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025.

Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

MIRA Pharmaceuticals announced the acceptance of a second peer-reviewed manuscript describing its lead oral drug candidate, Ketamir-2, in Frontiers in Pharmacology.

Senti Biosciences, Inc announced that it participated in a Virtual Investor "What This Means" segment.

IGC Pharma, announced promising preclinical results for IGC-M3, a novel small molecule designed to address multiple biological drivers of Alzheimer's disease.

Elicio Therapeutics, announced the publication of follow-up data from the Phase 1 AMPLIFY-201 study evaluating ELI-002 in the peer-reviewed scientific journal, Nature Medicine.

Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions.

AN2 Therapeutics, Inc. announced that it has completed dosing the first single ascending dose cohort in its Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers.

Ocular Therapeutix, Inc. announced it has received written agreement regarding a registrational trial design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company's planned clinical trial of AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).

Merck announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.

Nuvectis Pharma, Inc. announced the initiation of the Phase 1b program for NXP900.

Tiziana Life Sciences, Ltd. is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA).

INOVIO nnounced that peer-reviewed data from a retrospective study investigating the long-term clinical and safety response of patients treated with INO-3107 were published online in The Laryngoscope under the title "DNA Immunotherapy (INO-3107) Results in Long-term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP)."

IO Biotech announces topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted).

TriSalus Life Sciences® Inc is pleased to announce the publication of clinical data evaluating the use of its proprietary Pressure-Enabled Drug DeliveryTM (PEDDTM) technology in thyroid parenchymal embolization, a new application for the treatment of patients with symptomatic thyroid disease.

NRx Pharmaceuticals, Inc. announced US Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression.

Quantum BioPharma Ltd. announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS.

I-Mab announced that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in combination with nivolumab and mFOLFOX6, has been completed ahead of expectations.

GT Biopharma, Inc announced initiation of dosing in Cohort 3 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.

Stoke Therapeutics, Inc announced that the first patient has been dosed in the global Phase 3 EMPEROR study of zorevunersen for the treatment of Dravet syndrome.

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease.

Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Arvinas, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.

Capricor Therapeutics announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel, the Company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Assembly Biosciences, Inc announced positive interim antiviral activity, clinical outcomes, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-5366, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor, in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes.

Nutriband Inc. announced that the United States Food and Drug Administration (US FDA) has granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system).

Incannex Healthcare Inc announced new patient-reported outcome findings from a subset of participants in its RePOSA Phase 2 trial of IHL-42X for the treatment of obstructive sleep apnoea (OSA).

Orchestra BioMed Holdings, announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration ("FDA"), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.

Palisade Bio, Inc announced compelling new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor, including positive topline results from its Phase 1b open-label cohort in patients with moderate-to-severe UC and colon tissue pharmacokinetic (PK) data from the Phase 1a multiple ascending dose (MAD) cohort.

vTv Therapeutics Inc. announced the first study participant has been randomized in the Company's CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D).

SELLAS Life Sciences Group, Inc. announced that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), and has issued a positive recommendation to continue the trial without modification.

FibroGen announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial.

Cybin Inc announced that its Clinical Trial Application ("CTA") has been approved by the Irish Medicines Board, acting as the reference Member state, to initiate the EMBRACE™ study in Ireland, Poland, and Greece.

Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3,127 adults with obesity, or overweight with a weight-related medical problem and without diabetes.

OS Therapies announced that it held a successful Scientific Advice Meeting with the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) in July and has submitted an invited Innovative Licensing and Access Pathway (ILAP) application to begin the regulatory process towards approval of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.

Eledon Pharmaceuticals, announced updated data from the Company's ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

Immix Biopharma, Inc. announced important updates about its plan to address other serious diseases with its sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a "digital filter" that filters out non-specific activation.

RenovoRx, Inc. announced strong progress in its commercialization efforts, including its growing customer base and the hiring of experienced medical device sales leader Philip Stocton as Senior Director of Sales and Market Development to lead the execution of RenovoRx's commercialization efforts.

Keros Therapeutics, Inc. announced a strategic realignment designed to reallocate resources towards the development of its key clinical program, KER-065.

Mattel, Inc announced a partnership between its iconic Barbie™ brand and Quo Beauty®, the beloved and multi-award-winning Canadian beauty brand developed by Shoppers Drug Mart®. Available, August 11 nationwide, the all-new line includes colour cosmetics, cosmetic accessories, and hair accessories, all inspired by the Barbie™ brand's notable impact on beauty.

Cingulate announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301(dexmethylphenidate HCl), the company's lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Actuate Therapeutics, Inc. announced the initiation of the Phase 1b trial of elraglusib in combination with Incyte's PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX (mFOLFIRINOX) as frontline therapy in advanced pancreatic adenocarcinoma.

Moleculin Biotech, Inc., announced the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which demonstrated significant efficacy against various primary and metastatic liver cancers, including hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases.

SeaStar Medical Holding announced that it has successfully reached enrollment of 125 patients in the NEUTRALIZE-AKI pivotal clinical trial. Additionally, it has activated Methodist Hospital Metropolitan of San Antonio, Texas, as its 16th clinical trial site.

Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression.

BioXcel Therapeutics announced a publication in the peer-reviewed journal Frontiers in Pharmacology, entitled "Dexmedetomidine potently and reversibly regulates stress-mediated behaviors."

Adial Pharmaceuticals, Inc. announced the completion of a successful End of Phase 2 meeting (EOP2M) with the Food and Drug Administration (FDA). The FDA has provided input into the AD04 Phase 3 adaptive design clinical trial and the overall clinical program.

Lantheus Holdings, announced that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent filed by its affiliate, Aphelion.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.

Precision BioSciences, Inc announced ELIMINATE-B results as of the data cutoff of July 28, 2025.

Cardiol Therapeutics Inc. announced topline results from ARCHER, the Company's Phase II clinical trial in patients with acute myocarditis.

Galapagos NV announced that the United States Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL).

UroGen Pharma announced the 24-month DOR of 72.2% (95% CI 64.1%, 78.8%) by Kaplan-Meier estimate in patients who achieved CR at three months from the Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution, a treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Windtree Therapeutics, announced that it has performed a planned interim analysis of the SEISMiC C Phase 2 study data evaluating istaroxime in SCAI Stage C cardiogenic shock which showed istaroxime had a similar profile to that seen in previous studies despite a greater severity of illness and being used in addition to currently available inotropes and vasopressors.

Senti Biosciences, announced it has confirmed the recommended Phase 2 dose (RP2D) in its Phase 1 study of SENTI-202, the Company's potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, in development for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML).Inc.

Nuwellis, Inc. announced that the first patients have been successfully treated with Aquadex® ultrafiltration therapy in a hospital-based outpatient setting.

Clearmind Medicine Inc. announced that it has received Institutional Review Board (IRB) approval from Hadassah Medical Center, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).

Vivani Medical, Inc. today reported results from the LIBERATE-1 clinical study, the Phase 1 study of the exenatide GLP-1 implant NPM-115 representing the first-in-human test of the Company's proprietary NanoPortal™ implant technology.

Nuvation Bio Inc announced that new data will be presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025 in Barcelona, Spain, and the European Society of Medical Oncology Congress Meeting(ESMO) October 17–21, 2025 in Berlin, Germany.

Immutep Limited announces it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1).

Cocrystal Pharma, announces the presentation of favorable safety and tolerability data from a randomized, double-blinded, placebo-controlled Phase 1 study with its oral, direct-acting pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium (MHSRS), being held August 4-7 in Kissimmee, Florida. Inc

Nuvation Bio Inc. announced that new data will be presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025 in Barcelona, Spain, and the European Society of Medical Oncology Congress Meeting(ESMO) October 17–21, 2025 in Berlin, Germany.

Knight Therapeutics Inc., announced that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has submitted a marketing authorization application for CREXONT® to COFEPRIS, the Mexican health regulatory agency, for the treatment of Parkinson's disease (PD), post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.

Elicio Therapeutics, Inc. announced that following the Independent Data Monitoring Committee's ("IDMC") pre-specified interim review of the unblinded safety and efficacy data in the Company's Phase 2 AMPLIFY-7P study in mutant KRAS ("mKRAS")-driven pancreatic ductal adenocarcinoma ("PDAC"), the IDMC recommended that the trial continue to the final analysis without modifications.

Cadrenal Therapeutics, Inc announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis.

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.

Vertex Pharmaceuticals Incorporated announced topline results from its recently completed Phase 2, randomized, double-blind, placebo-controlled dose-ranging study evaluating the safety and efficacy of its investigational selective NaV1.8 pain signal inhibitor, VX-993, in treating acute pain after bunionectomy surgery.

AIM ImmunoTech Inc today highlighted recent key financial milestones and firmly stated its focus on advancing clinical trials of Ampligen® for the treatment of pancreatic cancer, with the ultimate goal of achieving drug approval.

CASI Pharmaceuticals, Inc. announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR).

Sonnet BioTherapeutics announced the expansion of its clinical study of patients with platinum-resistant ovarian cancer (PROC) (SB221).

Hyperfine, Inc announced the successful enrollment of 100 patients in its NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study just 16 weeks after the study initiation, announced on April 15, 2025.

Tharimmune, Inc. today issued a comprehensive corporate update highlighting significant advancements across its pipeline.

INmune Bio Inc. is pleased to report that its Phase I/II trial (the "CaRe PC" trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment.

Ainos, Inc. announced that its investigational low-dose oral interferon-alpha drug candidate, VELDONA®, has received formal approval from Taiwan's Food and Drug Administration (TFDA) to initiate a clinical study for primary Sjögren's syndrome (pSS).

TransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial.

Lineage Cell Therapeutics, Inc. announced that the first-ever chronic spinal cord injury patient has been treated in the Company's DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study at UC San Diego Health.

Dyne Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of patients with Duchenne muscular dystrophy (DMD), amenable to exon 51 skipping.

Dyne Therapeutics, Inc announced that potential BLA submission for U.S. accelerated approval anticipated in early 2026 -

Cassava Sciences, Inc. today reported positive preclinical results of a study evaluating simufilam in a well-accepted mouse model of tuberous sclerosis complex (TSC)-related epilepsy.

BioCardia®, today provides the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals of its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter.

Allogene Therapeutics, Inc announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL).

Exicure, Inc announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).

BioXcel Therapeutics, announced completion of the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial.

Viatris announced that five abstracts from its Phase 3 program evaluating novel fast-acting formulation of meloxicam (MR-107A-02) in moderate-to-severe acute surgical pain models will be presented at the PAINWeek 2025 national conference in Las Vegas from September 2-5, 2025.

Artelo Biosciences, announced that it has received written scientific advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the nonclinical development and first-in-human (FIH) clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP).