Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
Merck is diversifying its oncology pipeline beyond Keytruda as the blockbuster approaches patent cliffs, focusing on immune modulating therapies, antibody-drug conjugates, and tumor intrinsic treatments through strategic acquisitions and partnerships.
The FDA removed the clinical hold on Intellia Therapeutics' Phase 3 trial of nexiguran ziclumeran for transthyretin amyloidosis with cardiomyopathy. The hold was imposed in October following liver safety concerns in one patient.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
The global drug discovery services market is valued at $22.04 billion in 2025 and is forecast to reach $75.13 billion by 2034, growing at a 14.6% CAGR from 2026-2034, driven by rising industry demand and technological advancements.
A CNIC study demonstrates that remote ischemic conditioning can protect the heart during anthracycline chemotherapy without compromising antitumor efficacy, while researchers explore additional methods to manage chemotherapy side effects.
Researchers in China developed DeepRare, an AI-based diagnostic tool that achieved 69% accuracy in diagnosing rare diseases by combining patient symptoms, genetic data, and clinical notes, outperforming existing methods and expert opinion.
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
UCLA scientists developed a lipid nanoparticle-based gene editing system that successfully inserts a full-length healthy CFTR gene into human airway cells, offering potential treatment for cystic fibrosis patients unresponsive to current therapies.
The Federal Court of Australia granted AstraZeneca an interlocutory injunction on 16 February 2026 preventing Pharmacor from launching generic dapagliflozin products pending infringement proceedings, marking the second such injunction in three months.
Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease, marking the third global orphan designation for this indication based on positive phase 2 study data.
The FDA has accepted the New Drug Application for rusfertide, a first-in-class hepcidin mimetic peptide for polycythemia vera, and granted Priority Review with a PDUFA goal date in the third quarter of 2026.
uniQure received FDA feedback stating current AMT-130 data unlikely to support accelerated approval for Huntington's disease, while securities fraud lawsuits challenge prior disclosures. Fresh Fabry disease trial data showed elevated enzyme activity but prompted a dosing pause for safety review.
New research identifies a key microglial subpopulation regulated by anti-TREM2 antibody therapy in Alzheimer's disease, revealing how the treatment guides microglia toward protective differentiation pathways.
The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.
Phase III trial demonstrates belzutifan plus lenvatinib significantly improved progression-free survival versus cabozantinib in previously treated renal cell carcinoma patients, while neoadjuvant studies show promise for locally advanced disease.
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
