Vertex Pharmaceuticals (NASDAQ: VRTX) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 days. On Dec. 20, 2024, the FDA gave a thumbs-up to Alyftrek in treating ...

Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...

as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. ENHERTU is a specifically engineered HER2 ...

The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal ...

A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...

The FDA approved five fewer novel medicines than in 2023 while the EMA improved its tally by seven. Image credit: Shutterstock / Tamakhin Mykhailo. The US Food and Drug Administration (FDA) has ...

The US Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of the original reference biologic tocilizumab (Actemra), according to a January 30 announcement ...

Datopotamab deruxtecan-dlnk received approval from the FDA for previously treated unresectable or metastatic, HR-positive, HER2-negative breast cancer. The FDA granted approval to datopotamab ...

FDA approves Zyn nicotine pouches, including 10 flavors, as a safer option for adult smokers. The decision marks the first FDA authorization for nicotine pouches, which are tobacco-free.

For the first time, the U.S. Food and Drug Administration (FDA) has approved the use of a ketamine-like drug as a stand-alone therapy for adults with treatment-resistant depression (TRD).

--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo ® (ranibizumab ...