FDA approves a Merck BLA for Winrevair (sotatercept-csrk) for injection for treating adults with pulmonary arterial hypertension.
Federal Register proposed rule: FDA proposes to ban electrical stimulation devices intended for self-injurious behavior or aggressive behavior.
Federal Register notice: FDA makes available a guidance entitled Handling and Retention of BA and BE Testing Samples.
FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...
Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which may have caused del...
FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in adolescent patients...
FDA approves the latest version of Medtronics Evolut FX+ system to treat symptomatic severe aortic stenosis.
FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.
