FDA releases nine safety summaries for materials that are commonly used in implantable medical devices.
GlaxoSmithKline and Vir ask FDA to allow intramuscular administration of their Covid-19 monoclonal antibody treatment sotrovimab.
The Justice Department says Miamis Olga Torres pleaded guilty to obstructing an FDA inspection at the Florida clinical research site she co-owned.
FDA has cleared a G-Tech Medical 510(k) for its Wireless Patch System for myoelectric activity measurement as an aid in diagnosing and treating gastro...
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Becton, Dickinson for the BioGX SARSCoV2 Reagents for BD MAX System, B...
The Senate Health, Education, Labor & Pensions Committee votes to move FDA commissioner nominee Robert Califfs nomination to an eventual Senate floor ...
FDA revises fact sheets for the Janssen Covid-19 vaccine to discuss the risk of immune thrombocytopenia during the 42 days after vaccination.
FDA extends the expiration date on about one million unused Covid test kits in Florida.