FDA clears a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osartis BonOs Inject cemen...
FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension.
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-...
FDA opens a five-year collaboration with ConcertAI to evaluate real-world outcomes and safety in cancer treatments.