Sunovion Pharmaceuticals files an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patien...
FDAs Clinical Chemistry and Clinical Toxicology Devices Advisory Committee votes unanimously to recommend approval of Senseonics Holdings Eversense, a...
Federal Register notice: FDA announces a 5/24 public workshop on FY 2018 Generic Drug Regulatory Science Initiatives.
Federal Register notice: FDA announces a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advi...
The Government Accountability Office says that stakeholders have both positive and negative comments on FDA monitoring of the abortion drug Mifeprex a...
A New York federal judge approves an FDA consent decree with dietary supplement manufacturer and wholesaler Riddhi USA.
Federal Register notice: FDA makes available a revised draft guidance on generic doxycycline hyclate oral delayed-release tablets, entitled Product-Sp...
FDA releases an FDA-483 with 11 observations from a recent inspection at SCA Pharmaceuticals.