Omisirge® (omidubicel-onlv)

BL 125738

Omisirge® (omidubicel-onlv)

BL 125738

U.S. License Holder:

Gamida Cell Ltd.

Date of License:

April-17-2023

Last Update:

Feb-15-2026

approved_indications FDA-Approved Indications

OMISIRGE (omidubicel-onlv) is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of:

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;

Adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning.

Methodology

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