FDA clears a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degenerative spine procedur...
FDA gives 510(k) clearance to the Onkos Surgical 3D personalized pelvic reconstruction system.
FDA defers action on a BeiGene BLA for tislelizumab to treat some squamous cell carcinoma patients.
FDA completes an inspection in Denmark of Bavarian Nordics monkeypox vaccine manufacturing plant, a step that will lead to the release of thousands of...
Federal Register notice: FDA issues an order debarring Kris A. Hampton-Bey II for a period of five years from importing any drug into the U.S.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abametapir).
Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to safety or effective...
Washington Legal Foundation says a California appeals court should reverse a trial court ruling holding Gilead liable for not developing a different H...