Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products because it contained an i...
FDA denies a Zydus petition asking it to take certain actions regarding new applications citing Mephyton as the reference-listed-drug.
FDA grants Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma.
FDA debuts a Web page dedicated to FY 2018 GDUFA science and research outcomes.
BioCentury reports that President Trump will nominate MD Anderson Cancer Center chief medical officer Stephen Hahn to be the next FDA commissioner.
FDA says it is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taki...
FDA makes available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepa...
FDA issues a guidance to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replacement therapy produc...