Latest Biotech News

A KFF Health News analysis of FDA records highlights how postmarket study requirements are often delayed or underenrolled, leaving safety questions unresolved long after approvals. The reporting...

The EMA’s CHMP recommended approval of eight new medicines for September, including two new ovarian cancer therapies and a potential first oral treatment for hidradenitis suppurativa. The...

Electra Therapeutics raised $350 million in an upsized Nasdaq IPO to support late-stage development of ipsoprubart, a pan-SIRP monoclonal antibody in secondary hemophagocytic lymphohistiocytosis...

Xenon Pharmaceuticals paused enrollment in its major depressive disorder and bipolar disorder trials of azetukalner after neuropsychiatric adverse events appeared that were not seen in earlier...

Novo Nordisk and Orbis Medicines announced a $1.4 billion multitarget collaboration to discover oral cardiometabolic therapies using synthetic macrocycles designed for oral bioavailability. Orbis...

A report on autoimmune CAR-T development highlights how teams are grappling with fatal toxicities that test the field’s safety thesis. Developers point to multiple risk determinants for immune...

Palomar Labs (formerly Negev Labs) spun out Ariadne Bio to pursue AB-300, a clinical-stage non-hallucinogenic serotonin 2A receptor agonist targeting apathy in Parkinson’s disease. The venture...

Biopharma financing data shows a strong 2026 fundraising environment, with total biopharma financings reaching $77.13 billion through August and IPOs surging to $7.6 billion. The results track...

Anthropic confirmed it has established a wet lab in the San Francisco Bay Area for physical biology experiments, while declining to specify whether the facility is tied to drug discovery. Reuters...

The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, giving the rare pediatric disease its first disease-modifying treatment. The one-time...

Electra Therapeutics priced an upsized $350 million IPO, a significant cash infusion aimed at advancing its pan-SIRP monoclonal antibody ipsoprubart in secondary hemophagocytic lymphohistiocytosis...

Xenon Pharmaceuticals paused enrollment in its phase 3 major depressive disorder and bipolar disorder program for azetukalner after neuropsychiatric adverse events emerged in the larger patient...

Bavarian Nordic appointed Tarja Stenvall as president and CEO, effective Oct. 15, succeeding Paul Chaplin. Stenvall previously led Sanofi’s diabetes and cardiovascular franchise as an executive...

Apeximmune Therapeutics and Erasmus Medical Center reported a new immune checkpoint that could expand the pool of patients benefiting from antitumor immunotherapy. The work positions the target as...

Palomar Labs spun out Ariadne Bio to develop AB-300, a non-hallucinogenic 5-HT2A receptor agonist aimed at Parkinson’s disease apathy. Palomar said the company will pursue proof-of-concept through...

A KFF Health News analysis highlighted gaps in FDA-ordered postmarket studies, showing that long-running safety follow-ups can lag far behind original timelines. Using Tavneos as an...

Mithrl raised $20 million in a Series A to expand its AI platform for accelerating R&D through a biomedical “world model” and agentic tooling. The company said its next-generation system targets...

Novo Nordisk signed a deal with Orbis Medicines to discover oral “macrocycles” for cardiometabolic diseases, with total potential payments up to $1.4 billion. Orbis will use its nGen platform to...

Sartorius and Ireland’s NIBRT will launch a Process Intensification Training Center in Dublin to accelerate workforce capability for intensified and continuous bioprocessing. The center will use...

Ultragenyx won a key FDA decision for Sanfilippo syndrome type A, approving rebisufligene etisparvovec (Fayuvi) as the first disease-modifying therapy for the ultra-rare pediatric...