FDA says Sanofi did not submit sufficient data to justify approving an Aubagio sNDA for an indication for pediatric patients with relapsing forms of m...
FDA approves Stratatechs StrataGraft, a cellularized scaffold for treating adult patients with certain thermal burns.
Federal Register notice: FDA corrects a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants.
FDA extends the PDUFA action date for Ascendis lonapegsomatropin to 9/25.
The Justice Department says a Florida grand jury indicted five more individuals in a massive drug diversion scheme.
FDA warns the Web site at www.pharmacygeoff.md that it is selling misbranded unapproved new drugs in the U.S.
FDA grants Cerevel Therapeutics a fast track designation for CVL-871, a selective dopamine D1/D5 partial agonist in development for treating dementia-...
Federal Register notice: FDA announces a 7/14 meeting of it Medical Devices Advisory Committees Gastroenterology and Urology Devices Panel that will r...