FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.
FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac surgical procedures a...
FDA approves a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single-agent Jemperli for t...
FDA clears a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patients at risk for cardio...
FDA announces the FY 2024 user fee rates for medical device submissions.
Federal Register notice: FDA announces the rates for prescription drug/biologic user fees for fiscal year 2024.
Three Democratic U.S. Senators introduce the Drug Shortages Prevention and Quality Improvement Act that would give FDA and CMS additional authority to...
FDA expands the medical device Total Product Life Cycle Advisory Program pilot to include the Office of Neurological and Physical Medicine Devices.
