Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was approved 10/23.
Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing regimens for program...
FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial fail...
An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over the expedited pathw...
FDA warns Coquitlam, Canada-based AG Hair Limited about CGMP violations in its production of hand sanitizer drugs for the U.S. market.
FDA warns Glenmark Pharmaceuticals about CGMP violations in its production of finished drugs at a facility in Goa, India.
FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.
As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin decide to abandon develo...
