Federal Register notice: FDA withdraws approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
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.
