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FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.
FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Institute.
Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...
FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after ...
