Congresswoman Nanette Barragn (D-CA) reintroduces the Prompt Approval of Safe Generic Drugs Act, legislation that would remove hurdles in the ANDA app...
FDA tells Applied Therapeutics its govorestat is on track for the 11/28 PDUFA action date and will not need to go before an advisory committee.
Smiths Medical recalls (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect.
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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncology Multiregional Cli...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).
