FDA clears a Quantum Surgical 510(K) for its Epione, described as a robotic-assisted device designed to plan, target, deliver and confirm tumor ablati...
Federal Register notice: FDA establishes a docket to solicit comments that will assist the agency in determining how best to prioritize the addition o...
Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Cer...
FDA announces a 4/6 virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future Covid-19 v...
FDA posts a Cadila Healthcare (a Zydus Lifesciences company) Form FDA-483 that provides details of GMP violations identified in a 3/10 FDA Webview sto...
Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Cer...
New data from Washington University School of Medicine demonstrate that AstraZenecas Evusheld (tixagevimab co-packaged with cilgavimab) retains potent...
FDA approves Mercks Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is microsatellite instability-high or mism...