United States, Dec. 8 -- The U.S. Food and Drug Administration announced it has approved 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. SAA is a rare, life-threatening blood disorder where the bone marrow fails to produce enough red blood cells, white blood cells and platelets. Treatment for SAA depends on age and usually consists of either immunosuppressive therapy and/or h...