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Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.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.
FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonized protocol.
Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.
FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.
