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.
GLP-1 drugs have reshaped the treatment of obesity and diabetes, and innovation in the category is accelerating. The FDA approval of an oral version of Wegovy for chronic weight management marked a major milestone, expanding access to GLP-1 therapy and offering a new option for patients reluctant to use injections.
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.
Pharmaceuticals
Johnson & Johnson's termination of its Phase 2b study for JNJ-95475939 serves as a stark reminder that even the world's largest healthcare companies face brutal realities in drug development, despite investing $1.25 billion in the acquisition just 18 months earlier.
Biotechnology
Denali Therapeutics' tividenofusp alfa achieves historic NEJM publication as the first brain-penetrant enzyme replacement therapy for Hunter syndrome, with FDA decision expected by April 5, 2026.
Pharmaceuticals
Novo Nordisk achieved a critical milestone in the final days of 2025 when the FDA approved the first oral GLP-1 medication for weight loss, positioning the Danish pharmaceutical giant for what analysts describe as a "must-win" battle in the increasingly competitive obesity treatment market. The approval of Wegovy
Biotechnology
BioMarin Pharmaceutical's announcement of its $4.8 billion acquisition of Amicus Therapeutics represents one of the most significant consolidation moves in the rare disease sector, signaling a new era of strategic positioning as companies seek to build comprehensive portfolios in specialized therapeutic areas. The all-cash transaction, announced December
Biotechnology
Omeros Corporation launches YARTEMLEA, the first and only FDA-approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), offering hope to thousands of patients facing a condition with mortality rates exceeding 90% in severe cases.
Biotechnology
Insilico Medicine completes Hong Kong's largest biotech IPO of 2025, raising $292 million and becoming the first AI-driven biotech company to list on the Hong Kong Stock Exchange's Main Board.