Citing lingering questions about pulse oximeters, four Senate Democrats urge FDA to initiate a post market study of the devices.
FDA grants Daiichi Sankyo accelerated approval for Enhertu for treating adult patients with unresectable or metastatic non-small cell lung cancer.
Attorney Sara Koblitz says an Avadel suit against FDA challenges the agency's authority to list some patents in the Orange Book and require certificat...
FDA says its clinical hold on a MaaT Pharma Phase 3 trial of an investigational graft-versus-host disease drug remains in place while the company prov...
Federal Register notice: FDA seeks comments on an information collection extension entitled "Mammography Quality Standards Act Requirements: CFR part ...
Federal Register notice: FDA sends to OMB an information collection revision entitled: "Environmental Impact Considerations."
Federal Register notice: FDA sends to OMB an information collection extension entitled "Medical Device Accessories."
FDA says the Becton Dickinson recall of three intraosseous medical devices is Class 1.
