FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved m...
Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough syrups and other produ...
The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV drugs into interstate ...
Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing ...
Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic form of Vandas Hetlioz...
Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in INDs and BLAs submitte...
FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastatic ovarian cancer wit...
Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with familial chylomicro...
