Federal Register notice: FDA announces the renewal of its Pharmacy Compounding Advisory Committee for an additional two years.
Federal Register notice: FDA publishes a listing of recent OMB-approved information collections.
Federal Register notice: FDA announces the renewal of its Drug Safety and Risk Management Advisory Committee for an additional two years.
Federal Register notice: FDA announces the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years.
FDA clears an Optovue 510(k) for its AngioAnalytics, an optical coherence tomography angiography blood vessel measurement technology to help clinician...
FDA approves an Amgen supplemental NDA to add positive overall survival data from the Phase 3 ASPIRE trial to the prescribing information for Kyprolis...
FDA clears a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices.
FDA approves a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with b...