The Institute for Clinical and Economic Review asks FDA to reconsider the implications of its stated goal in a draft guidance on clinical trial divers...
FDA approves an additional indication for Mercks Keytruda with chemotherapy to treat unresectable advanced or metastatic malignant pleural mesotheliom...
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...
