Tag Archives: Blood Cancer

July, 2018

June, 2018

January, 2018

November, 2017

October, 2017

September, 2017

  • 13 September

    FDA Accepts for Review Sandoz’s BLA for Proposed Biosimilar Rituximab

    Holzkirchen, September 12, 2017 – Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). Rituxan®** is used to …

  • 7 September

    FDA Places Clinical Hold on Celgene’s Fusion Clinical Program

    SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION™ program. The trials are testing IMFINZI™ (durvalumab), an anti-PD-L1 antibody, in combination with immunomodulatory and chemotherapy agents …