Zhongmou Therapeutics Reports First-in-Human Success of Optogenetic Gene Therapy ZM-02 for Retinitis Pigmentosa on November 28, 2025 AAV Vector First-in-Human Clinical Trial gene therapy Ophthalmology specialty Optogenetic Gene Therapy PsCatCh2.0 Retinitis Pigmentosa Vision Restoration Zhongmou ZM-02 +
Vera Therapeutics Appoints James R. Meyers to Its Board of Directors on November 27, 2025 Appointments Atacicept Autoimmune Diseases Biological Factors biotech executive Board of Directors Gilead Sciences IGA Glomerulonephritis IntraBio Ltd. James Vera Therapeutics +
Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management on November 27, 2025 Chinese Language Clinical Research Gan & Lee Pharmaceuticals Glucagon-Like Peptide 1 GRADUAL-3 innovation once-monthly Phase 3 Rheumatoid Arthritis Weight maintenance regimen +
Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny on November 26, 2025 Approved BiomX Clinical Imfinzi Malignant neoplasm of cardioesophageal junction of stomach Malignant neoplasm of stomach Nebulizers perioperative United States Food and Drug Administration +
Otsuka's Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN) on November 26, 2025 anti-APRIL antibody Approved IGA Glomerulonephritis Monoclonal Antibodies Otsuka Proteinuria Sibeprenlimab United States Food and Drug Administration Voyxact +
FDA Delays Decision on Ascendis' Dwarfism Drug by Three Months on November 26, 2025 Achondroplasia Approved Ascendis Pharma CNP gene Deferred Dwarfism navepegritide PDUFA post-marketing requirement TransCon United States Food and Drug Administration +
FDA OKs Sarepta Study of New Immune Suppression Approach with Elevidys; Gilead Acquires Preclinical TREX1 Program on November 26, 2025 acute liver injury Elevidys gene therapy Gilead Muscular Dystrophy, Duchenne sirolimus Therapeutic immunosuppression TREX1 gene United States Food and Drug Administration +
CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks on November 26, 2025 drug price Effectiveness Inflation Reduction Act Medicare Part D Myasthenic Syndromes, Congenital negotiation Ozempic Prices semaglutide Wegovy +
Zentek Appoints Mohammed Jiwan as CEO on November 26, 2025 Appointments CEO commercialization Graphene Jiwan Mohammed Nanostructured Materials Technology ZenGUARD Zentek +
Curapath and Cristal Therapeutics Sign Co-Exclusive License of CliCr Bioconjugation Platform on November 26, 2025 Bioconjugation Platform CDMO CliCr co-exclusive license Cristal Therapeutics Curapath Drug Delivery Systems nucleic acid delivery +
Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade on November 26, 2025 Approved Chronic Spontaneous Urticaria Dupixent EU Interleukin-13 interleukin-4 Monoclonal Antibodies Regeneron sanofi type 2 inflammation +
Novartis Announces Plans to Lay Off 550 Workers at Swiss Factory on November 25, 2025 Investments layoffs Novartis pharmaceutical manufacturing restructuring Schweizerhalle Stein facility Switzerland +
Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect on November 25, 2025 AstraZeneca Centers for Medicare & Medicaid Services drug price Farxiga Inflation Medicare negotiation petition pharmaceutical lawsuits price controls SCOTUS Supreme Court +
FDA's Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement on November 25, 2025 CNPV Commissioner 's National Priority Voucher Drug Approval Process internal disagreement legality Pazdur Tidmarsh Tumor board United States Food and Drug Administration +
Accelerating Breast Cancer Treatment Planning with Agentic AI: Recent Advances and Implementations (2025) on November 25, 2025 Agentic AI AI-guided AWS HealthLake Clinical Decision Support DNA Integration healthcare workflow Malignant neoplasm of breast Microsoft Teams multi-agent systems Neoplasms Precision Medicine +
ASH 2025: Breakthroughs in In Vivo CAR-T Data from Kelonia; Phase 3 Wins for Lilly, J&J, and Novartis on November 25, 2025 2025 Asymmetric Septal Hypertrophy CAR-T CAR-T therapy Eli Lilly in vivo Kelonia Therapeutics Multiple Myeloma Novartis Phase 3 trials +
FDA Approves Novartis' Itvisma: Expanding Gene Therapy to Older Spinal Muscular Atrophy Patients on November 25, 2025 Adult Approved gene therapy intrathecal formulation Itvisma Novartis older children Spinal Muscular Atrophy United States Food and Drug Administration Zolgensma +
Rakovina Therapeutics Showcases Compelling Preclinical Data on AI-Discovered CNS-Penetrant ATR/mTOR Inhibitors at the 2025 Society for Neuro-Oncology Annual Meeting on November 25, 2025 AI-discovered drugs ATR ATR/mTOR Inhibitors Brain Neoplasms CNS-penetrant dual pathway inhibition Enki generative AI preclinical data PTEN-deficient tumors Rakovina Society for Neuro-Oncology +
Johnson & Johnson Halts Phase 2 Alzheimer’s Trial After Tau Antibody Failure on November 24, 2025 Alzheimer 's disease Clinical Failure Clinical Trials discontinued Johnson & Johnson posdinemab tau-targeting antibody +
Bayer Stock Rallies as Next-Gen Blood Thinner Achieves Phase 3 Success on November 24, 2025 Bayer blood thinner earnings Phase 3 trial rally +
Novo Nordisk's Semaglutide Misses Key Goals in Closely-Watched Alzheimer’s Disease Phase 3 Trials on November 24, 2025 Alzheimer 's disease Biological Markers clinical trial failure EVOKE trial Glucagon-Like Peptide 1 Mental deterioration Novo Nordisk Phase 3 Rybelsus semaglutide +
White House Requests Resignation of Top FDA Aide, Prompting Tensions with Commissioner Makary on November 24, 2025 CHARGE Syndrome controversy internal tensions management technique Marty Makary resignation Sanjula Jain-Nagpal United States Food and Drug Administration White House Workforce - population group +
As Drug Resistance Rises, GramEye and GSK Advance New AI-Led Infectious Disease Research on November 24, 2025 AI-driven Antibiotics Antimicrobial Resistance Clinical Trials Communicable Diseases Drug Discovery Gram-negative bacteria GramEye Mycoses research SmithKline Beecham Staphylococcus aureus superbugs +
AstraZeneca Onshores Rare Disease Portfolio as Part of $50B US Investment Pledge on November 24, 2025 AstraZeneca expansion Infrequent Investments Maryland (geographic location) onshoring pledge portfolio R&D U.S. Virginia facility +
GSK and AnaptysBio Enter Legal Dispute Over Jemperli License Amid Allegations of Contract Breaches on November 21, 2025 AnaptysBio dostarlimab Jemperli license agreement Litigation Malignant neoplasm of endometrium Neoplasms royalties SmithKline Beecham TESARO +
Eli Lilly Becomes First Drugmaker to Reach $1 Trillion Valuation on November 21, 2025 capitalization Drug Industry eli lilly Glucagon-Like Peptide 1 Market Mounjaro valuation Weight-Loss Agents Zepbound +
FDA Breakthrough Designations Lead to Priority Reviews, Report Finds on November 21, 2025 biotechnology innovation Breakthrough Therapy CDER Drug Approval expedited pathway Identifier Infrequent Neoplasms Priority Review regulatory science United States Food and Drug Administration +
FDA Grants Regeneron Two Eylea HD Approvals in One Day on November 21, 2025 aflibercept Approved dosing Eylea Hodgkin Disease Macular retinal edema monthly Ophthalmology specialty Regeneron Retinal Vein Occlusion RVO United States Food and Drug Administration +
Edgewise Therapeutics Appoints Christopher Martin to its Board of Directors on November 21, 2025 acquisition Becker Muscular Dystrophy Board of Directors cardiovascular asset Christopher Martin commercial Edgewise Therapeutics executives Leadership Merck Verona Pharma +
ViVac Pharma Appoints Keren Leshem as CEO to Advance RNA-LNP Cancer Immunotherapy on November 21, 2025 Appointments Biotechnology CEO Immunotherapy for cancer Keren Leshem Leadership RNA-LNP ViVac Pharma +
Oncolytics Biotech Provides Update on Special Meeting of Shareholders on November 21, 2025 biotech corporate government jurisdiction Nevada Nevada <Geographic Area> Oncolytics rescheduling shareholders shutdown update +
Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants on November 21, 2025 4,4-difluoro-5,7-dimethyl-4-bora-3a,4a-diaza-3-indacene Cantor clinical-stage pharmaceutical Inhibikase Therapeutics Jefferies pre-funded Pricing public entity +
Researchers Advance Toward Matching Patients with the Most Effective GLP-1 Drug for Personalized Obesity Treatment on November 21, 2025 aspects of adverse effects drug response Genetic screening method Glucagon-Like Peptide 1 Machine Learning Mayo Clinic MyPhenome Obesity personalized care Precision Medicine Prediction Treatment Adherence +
EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements on November 21, 2025 algorithm Clearance Edap Malignant neoplasm of prostate Medical Devices robotic HIFU United States Food and Drug Administration +
AI Proteins Raises $41.5M Series A to Accelerate AI-Designed De Novo Miniprotein Therapeutics on November 20, 2025 AI Proteins Artificial Intelligence BioCapital Biotechnology de novo miniproteins Drug Discovery Religious Missions Santé Ventures Series A financing Synthetic Biology therapeutic protein +
GSK and LTZ Therapeutics Announce $50M Partnership to Develop First-in-Class Myeloid Cell Engagers for Cancer on November 20, 2025 Biotechnology engagers hematologic cancers Immunotherapy letrozole Myeloid Progenitor Cells Neoplasms preclinical programs SmithKline Beecham Solid Neoplasm strategic collaboration upfront +
Agios' Sickle Cell Trial Falls Short as Mitapivat Fails to Significantly Reduce Pain Crises on November 20, 2025 Agios Anemia, Sickle Cell Clinical Trials hemoglobin response mitapivat pain crises PYRUKYND Rise Up trial +
PBMs and FTC Battle in Court Over In-House Insulin Pricing Challenge Intensifies on November 20, 2025 administrative proceedings antitrust lawsuit Caremark Rx drug affordability Express Scripts Insulin PBMs Pricing rebate schemes United States Federal Trade Commission +
Novartis Raises Sales Targets for Key Cancer Drugs, Tweaks Yearly Growth Guidance on November 20, 2025 cancer drugs Drug Industry Kisqali leukemia Malignant neoplasm of breast Novartis peak sales Pluvicto sales guidance Scemblix +