FDA reports on the latest three months of medical device reports on some Philips Respironics ventilators, BiPAP, and CPAP machines.
FDA approves Behrings Hemgenix to treat some adults with Hemophilia B.
FDA announces a 1/26/2023 Webinar entitled FDAs Labeling Resources for Human Prescription Drugs that will discuss new resources available for the phar...
FDA updates a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user acc...
Federal Register notice: FDA corrects a 9/28 notice entitled Statement of Organization, Functions, and Delegations of Authority that discussed a reorg...
FDA clears a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement.
FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwin...
Federal Register notice: FDA announces a 12/8 Science Board to the FDA Advisory Committee meeting that will hear research needs for evaluating oral ca...
