The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...

Ralph Abraham, a vocal vaccine skeptic who served at the agency for just three months, has stepped down due to “unforeseen ...

A lower court had previously ruled for Sarepta in the companies’ long-running dispute, finding that REGENXBIO’s AAV patent ...

Guerbet's innovation, Elucirem™ is the first gadolinium-based contrast agent approved at half dose of gadolinium, and with ...

After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has ...

The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are ...

The new structure will help Merck as it slides toward a loss of exclusivity for Keytruda, pharma’s best-selling drug.

Head-to-head trials are often reserved for approved therapies as drugmakers try to one-up each other to gain further market share. In this case, Novo Nordisk ran the test at the candidate stage, and ...

Bysanti is based on iloperidone, an active metabolite of a compound that forms the core of Fanapt, another drug by Vanda Pharmaceuticals.

The U.S. Congress greenlit a historic $315 million in federal ALS research funding for 2026 amid Rare Disease Month, spotlighting biotech progress like VectorY Therapeutics' first patient dosing in ...

PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with ...

Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.