Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implementation.
FDA clears an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care.
Former FDA associate chief counsel for litigation James Fraser joins Greenberg Traurig.
Moderna submits trial data to FDA for an evaluation of its Covid vaccine booster shot.
The chairs of two House committees ask FDA for detailed responses to 15 questions about the review and accelerated approval of Biogens Aduhelm.
Takeda Pharmaceutical reports disappointing data from its blood cancer Phase 3 PANTHER (Pevonedistat-3001) study, which did not achieve pre-defined st...
FDA accepts for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilsons Disease.
Attorney Jordan Thomas asks FDA to halt clinical trials of Cassava Sciences simufilam until the agency thoroughly evaluates the scientific support for...