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...
Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.
Novo Nordisk files a supplemental NDA seeking approval for a higher-dose version of weight-loss drug Wegovy (semaglutide).
