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...
Federal Register notice: FDA announces an 11/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Levo Therapeutics NDA for Prader-Will...
FDA orders a drug class warning for Janus kinase inhibitors after reviewing a recent clinical trial that showed an increased risk of serious heart-rel...