FDA commissioner Marty Makary defends CBER director Vinay Prasad from recent criticism by Trump confidant Laura Loomer.
FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating menopause-rel...
FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are potentially putting can...
Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in whic...
Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in modera...
Five House members introduce a bill to require DTC television ads to include the drugs list price.
Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with Gilead Sciences to resolve charges that the compan...
Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional funding and take steps to improve transparency an...
