Biotechnology
French biotech 4Moving Biotech achieves FDA IND clearance for 4P004, a first-in-class intra-articular GLP-1 therapy targeting osteoarthritis, potentially becoming the first disease-modifying osteoarthritis drug (DMOAD) to reach patients.
Biotechnology
In a landmark achievement that could transform treatment for one of neuro-ophthalmology's most challenging conditions, Oculis Holding AG announced on January 6, 2026, that the FDA has granted Breakthrough Therapy Designation to Privosegtor for the treatment of optic neuritis. This designation marks the first time any investigational therapy
Biotechnology
Revolution Medicines announces FDA Breakthrough Therapy Designation for zoldonrasib, marking the first investigational drug specifically targeting the KRAS G12D mutation to receive this prestigious regulatory recognition.
Biotechnology
Krystal Biotech announces interim clinical results from its Phase 1 CORAL-1 study of KB407, a potentially mutation-agnostic gene therapy for cystic fibrosis that could transform treatment for all CF patients.
Biotechnology
Jazz Pharmaceuticals announces unprecedented survival outcomes for Ziihera in HER2-positive gastroesophageal adenocarcinoma, achieving over two years median overall survival—the longest ever reported in a Phase 3 trial for this disease.
Pharmaceuticals
GSK and Ionis announce historic functional cure rates for chronic hepatitis B in Phase III trials with bepirovirsen, potentially transforming treatment for 250 million patients worldwide.
Biotechnology
MediWound has a product already on the market, no long-term debt, substantial non-dilutive government funding, and a Phase III asset going after a market dominated by a single 60-year-old drug Chronic wounds are not something most investors think about. But they should. More than 10 million Medicare beneficiaries in the
Biotechnology
Fractyl Health outlines ambitious 2026 roadmap positioning its Revita system as the first FDA-approved solution for maintaining weight loss after GLP-1 discontinuation, with pivotal clinical data expected this month.
Biotechnology
Ascletis Pharma announced FDA IND clearance for ASC30, an oral small molecule GLP-1 receptor agonist for diabetes treatment, marking a significant milestone in the competitive GLP-1 market with a differentiated approach to injectable peptide therapies.
Pharmaceuticals
January 4, 2026, marks a watershed moment in the global GLP-1 market as Canada becomes the first country where Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic loses patent protection. Leading the charge into this newly opened market is Toronto-based Vimy Pharma, a startup founded by former Novo
Biotechnology
Insilico Medicine announces an $888 million multi-year collaboration with Servier, representing one of the largest AI-driven drug discovery deals to date and validating the commercial viability of AI in pharmaceutical research.
Pharmaceuticals
Axsome Therapeutics announces FDA Priority Review for AXS-05 in treating Alzheimer's disease agitation, with a PDUFA target action date of April 30, 2026, offering hope for millions affected by this challenging behavioral symptom.