FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...
Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-paclitaxel significantly ...
Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device.
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...