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...
The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.
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.