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.
FDA warns patients and providers about the potential for dental problems associated with dissolving buprenorphine products in the mouth to treat opioi...
FDA accepts for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sclerosis.
Washington University in St. Louis law professor Rachel Sachs says a CMS restricted coverage determination for Biogens Aduhelm adds to questions about...