Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
Australian regulators confirmed counterfeit GLP-1 products contain no active ingredients, while U.S. authorities escalate enforcement against compounded weight-loss drugs as Novo Nordisk sues telehealth company Hims & Hers.
Over 100 children with rare diseases in India have exhausted the Rs 50 lakh financial assistance limit under the National Policy for Rare Diseases 2021, forcing treatment halts and prompting urgent appeals for continued support.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Union Minister Dr. Jitendra Singh announced the first national call for the ₹2,000 crore BIRAC–RDI Fund under India's ₹1 lakh crore Research, Development, and Innovation initiative, marking a major push to scale biotechnology innovations and strengthen India's position in the global biotech race.
A new Cochrane review analyzing 22 randomized clinical trials involving 1,995 adults found intermittent fasting produces no clinically meaningful weight loss compared to traditional dietary advice or no intervention.
Regeneron has consistently increased revenue over 35 years with blockbuster products like Dupixent and Eylea HD, while maintaining over a dozen phase 3 clinical trial candidates across multiple therapeutic areas.
New research demonstrates that physical activity after cancer diagnosis reduces mortality risk in less common cancers and enhances circadian clock function in tumor tissue, supporting exercise as a therapeutic intervention.
