FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up its drug substance m...
Federal Register notice: FDA posts a final guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.
Federal Register notice: FDA announces the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA issues an order to permanently debar Analay Rico from providing services in any capacity related to an approved or pendin...
A group of bipartisan senators introduce the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrigs Disea...
Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integrating artificial int...
FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of...
An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens Leqembi (lecanemab) ...
