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 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advi...
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Federal Register notice: FDA makes available a revised draft guidance on generic doxycycline hyclate oral delayed-release tablets, entitled Product-Sp...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.
Federal Register notice: FDA seeks OMB approval for a new information collection entitled Guidance for Industry on Compounded Drug Products That Are E...
FDA and NIH officials make the case for research into biomarkers that can predict efficacy of new opioid-abuse drugs based on reducing the quantity a...