Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the investigational exon-skipp...
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 approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.
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.
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committe...
FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotexs sterile drug facil...
CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine withi...
