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 publishes its report on an 11/2023 workshop on increasing clinical trial diversity.
Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.
Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee Educational Conferenc...
A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healthcare fraud.
FDA asks for input on certain non-device software functions and impacts on patient safety.
