FDA accepts for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indication for Dificid tab...
FDA approves a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast ...
Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons.
Federal Register notice: FDA announces an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to discuss immunological...
Federal Register notice: FDA makes available a draft guidance on Patient-Focused Drug Development: Methods To Identify What Is Important to Patients....
FDA warns South Koreas Dermameal about CGMP violations in its role as a contract manufacturer of finished pharmaceuticals.
FDA awards a five-year contract that could be worth $220 million to Harvard Pilgrim Health Care Institute for the next phase of the Sentinel project.
FDA provides information about the Urgent/11 cybersecurity vulnerability that could affect medical devices.