Novartis Approval for Gene Therapy Signals New Cancer Treatment Era

The U.S. Food and Drug Administration gave a green light to Novartis AG's leukemia treatment, marking the first time that a highly anticipated new type of potent gene-modifying immunotherapy has gained approval in the United States.

First Dagabitran Reversal Agent Approved

  • Dabigatran anti-coagulation can now be reversed.
  • FDA approves idarucizumab for reversal of dabigatran anti-coagulation.
  • Normal coagulation is established “in minutes.”
  • Preliminary data show idarucizumab to be safe and effective for reversal of dabigatran anti-coagulation.
  • Both efficacy and safety trials are sponsored by the manufacturer and published in top-tier journals.