Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Blenrep (belantamab mafodotin-...
Summit Therapeutics says it is considering whether to hold at least one more clinical trial of its C. Diff treatment radinilazole as discussed at a me...
Teva asks the Supreme Court to hear its appeal of an Appeals Court decision invalidating its skinny label on a generic version of GlaxoSmithKlines Cor...
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.