FDA lifts a partial clinical hold on an AbbVie/Genentech Phase 3 CANOVA (M13-494) trial evaluating venetoclax for the investigational treatment of rel...
FDA issues a five-page Form 483 after it inspected a Sun Pharmaceutical Industries Gujarat, India manufacturing facility 6/3-11.
An FDA Advisory Committee unanimously agrees that data show a mortality signal associated with paclitaxel-coated products, but they were uncertain as ...
FDA updates its List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.
FDA Review posts the Federal Register notices for the week ending 6/21/2019.
FDA Review posts product approval summaries for the week ending 6/21/2019.
Federal Register notice: FDA announces that it issued a priority review voucher to AveXis for gaining approval for its rare pediatric disease product ...
FDA acting commissioner Ned Sharpless tells the Washington Post that he would like to be nominated by President Trump as the next agency commissioner.