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...
Federal Register notice correction: FDA corrects a 2/12/2018 Federal Register notice to revise the regulatory review period for Mercks Bravecto (flura...
Viona Pharmaceuticals recalls two lots of diabetes drug metformin HCl 750mg because the product was found to contain levels of human carcinogen nitros...