[ Price : $8.95]
FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.[ Price : $8.95]
FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.[ Price : $8.95]
FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.[ Price : $8.95]
FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatm...[ Price : $8.95]
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.[ Price : $8.95]
FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...[ Price : $8.95]
FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...