Omisirge® (omidubicel-onlv) – New orphan drug approval
April 17, 2023 - The FDA announced the approval of Gamida Cell’s Omisirge (omidubicel-onlv), 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.
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