[ Price : $8.95]
Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was ap...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing ...[ Price : $8.95]
FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a con...[ Price : $8.95]
An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over...[ Price : $8.95]
FDA warns Coquitlam, Canada-based AG Hair Limited about CGMP violations in its production of hand sanitizer drugs for the U.S. mar...[ Price : $8.95]
FDA warns Glenmark Pharmaceuticals about CGMP violations in its production of finished drugs at a facility in Goa, India.[ Price : $8.95]
FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.[ Price : $8.95]
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 deci...