FDA accepts for review a Byondis BLA for SYD985 ([vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresectable locally advanced...
FDA grants an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test.
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emulsion.
Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants because the products are no longer marketed.
A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses into the U.S.
FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.
FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.
FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.