Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from fraudulent vaccine tr...
FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office of Womens Health in i...
Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers disease.
Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for certain infants.
FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart access.
Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.
FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approved pediatric disease...
