Top House Democrats demand FDA provide documents and explanations after revelations that a senior FDA official circulated new vaccine development guid...
A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements.
FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026 midterm elections.
BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with advanced squamous no...
FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both transfusion-dependent...
Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the investigational exon-skipp...
FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.
A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting ...
