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 ...
FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.
Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical trials by underreprese...
