FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks departure ...
Vanda Pharmaceuticals files an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia.
FDA approves AstraZenecas Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer.
President Trump signs an executive order to remove organized union representation from the majority of government agencies, including FDA, to make it ...
Merck reports data from its Phase 3 ZENITH trial that showed Winrevair (sotatercept-csrk) significantly reduces the risk of major morbidity and mortal...
FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating people with sequelae of stroke and spinal cord injur...
Eastern Texas federal judge Sean Jordan rules against FDA in a case challenging the agencys final rule regulating laboratory-developed tests.
FDA grants Visby Medical a de novo marketing clearance for its Womens Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, go...
