Tag Archives: Arzerra

August, 2016

  • 31 August

    FDA Expands Approval of Genmab, Novartis’ Arzerra in CLL

    Copenhagen, Denmark; August 31, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic …

March, 2016

  • 11 March

    Genmab Submits its Supplemental BLA to the FDA for its CLL Combo

    Copenhagen, Denmark; March 10, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) in combination with  fludarabine and cyclophosphamide (FC) for the treatment of patients with …

April, 2015