FDA says it has deployed advanced agentic AI capabilities to all agency employees, marking a major expansion of its artificial intelligence tools for ...
FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.
Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications...
FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat edema in adults wit...
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gas...
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasi...
FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.
Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questions that remain about...
