Jazz Pharmaceuticals says data from its Phase 2b clinical trial evaluating the efficacy and safety of suvecaltamide in adult patients with essential t...
Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.
FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.
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.
