FDA approves AstraZenecas Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis.
Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in certain patients with locally advanced non-small ...
Federal Register notice: FDA announces an 11/20-21 Digital Health Advisory Committee meeting to discuss generative artificial intelligence-enabled dev...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncology Multiregional Cli...
Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (special controls).
FDA publishes a guidance on integrating clinical trials into routine clinical practice.
FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip System Femoral Stem 1...
FDA publishes a guidance on the conduct of clinical trials with decentralized elements.
