‘Revolutionary’ approval for Gamida Cell’s Omisirge

9 December 2025

Florida-based cell therapy company Gamida Cell has won US approval for Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA).

Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies, and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.

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