FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bioadaptor System for ...
FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by...
FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder.
FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT326/YL202 in certain...
FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or recurrent endometrial ...
Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agency intends to assign ...
FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facility 3/25 to 4/2.
