PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading partners may not be rea...
FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treatment of certain peop...
FDA lifts a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human trigg...
In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.
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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncology Multiregional Cli...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).
