• Regulatory NewsRegulatory News

    CBER Director Highlights Firsts in FY2017 Report

    In his second annual report as the director of the US Food Administration's (FDA) Center for Biologics Research and Evaluation(CBER), Peter Marks said the center continued to meet or exceed its performance goals in the final year of the last Prescription Drug User Fee Act (PDUFA V). According to Marks, CBER exceeded its PDUFA goals by completing 100% of its FY2017 cohort of standard and priority biologics license application (BLA) and new drug application (NDA) reviews...
  • Regulatory NewsRegulatory News

    'Historic Action': FDA Approves First CAR-T Therapy

    The US Food and Drug Administration (FDA) on Wednesday approved the first gene therapy, Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Dubbed an "historic action" by the agency, the approval comes a little more than a month after FDA's Oncologic Drugs Advisory Committee voted unanimously , 10 to 0, in favor of the benefit-risk profile for the first of this new kind of cancer th...