FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by Abiomed that could t...
A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufacturers respond to insp...
Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy failed to meet primary an...
FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer who are n...
FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking the first FDA-approv...
Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.
React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause ser...
FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.
