U.S. License Holder:
Gamida Cell Ltd.
Date of License:
April-17-2023
Last Update:
Sep-30-2024
FDA-Approved Indications
OMISIRGE (omidubicel-onlv) is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.