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FDA clears a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degener...[ Price : $8.95]
FDA gives 510(k) clearance to the Onkos Surgical 3D personalized pelvic reconstruction system.[ Price : $8.95]
FDA defers action on a BeiGene BLA for tislelizumab to treat some squamous cell carcinoma patients.[ Price : $8.95]
FDA completes an inspection in Denmark of Bavarian Nordics monkeypox vaccine manufacturing plant, a step that will lead to the rel...[ Price : $8.95]
The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.[ Price : $8.95]
Federal Register notice: FDA issues an order debarring Kris A. Hampton-Bey II for a period of five years from importing any drug i...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abameta...[ Price : $8.95]
Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to...