FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jbvf) and Biogens Opuv...
FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.
FDA chief medical officer Hilary Marston discusses the future of clinical research and new initiatives to support clinical trial innovation.
FDA removes a partial clinical hold on Larimar Therapeutics nomlabofusp (CTI-1601), which is being evaluated for treating patients with Friedreichs At...
Federal Register notice: FDA announces the revocation of the emergency use authorizations issued to Bio-Rad Laboratories for the Bio-Rad SARSCoV2 ddPC...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on the design ...
FDA issues Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their combination rivoceranib ...
