A CDER online post updates the Centers efforts to support rare disease drug development, particularly through data sharing initiatives that are import...
FDA issues South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% Liquid) because the ...
Federal Register notice: FDA makes available a final guidance entitled Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.
Federal Register notice: FDA debars George Kuiper for a period of five years from importing or offering for import any drug into the U.S. due to felon...
FDA grants DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring system for use in the hospital setting.
Sens. Collins and Capito ask the Centers for Medicare and Medicaid Services to ensure that its national coverage decision on Aduhelm does not restrict...
FDA extends by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (umbralisib), indicate...
Median Technologies files a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screening Artificial Intelli...