FDA clears a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infections.
FDA places a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 di...
FDA denies a Nautilus Gloves request that the agency not rescind its 510(k) clearance for nitrile exam gloves and instead allow the company to substit...
Two stakeholders provide comments and questions on the latest FDA draft guidance on developing drugs to treat early Alzheimers disease.
Medtronic recalls (Class 1) five versions of its StealthStation S8 neurological navigation device after customer complaints about a software error.
FDA warns Mississauga, Canada-based Trexo Robotics Holdings about QS issues in its illegal manufacturing and marketing of robotic medical devices.
FDA publishes a draft guidance outlining the standardized format for electronic submission of BLA, NDA, and selected supplements for planning CBER Bio...
Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing.
