Catalyst says it has settled its patent litigation with Jacobus over Catalysts Firdapse and Jacobus Ruzurgi.
Federal Register notice: FDA extends the comment period on a draft guidance entitled Risk Management Plans to Mitigate the Potential for Drug Shortage...
FDA warns Elite Supplement Center that it is illegally marketing selective androgen receptor modulator products that are legally considered to be unap...
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.