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.
- 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.