FDA approves Omisirge cell therapy to reduce infection risk in blood cancer patients.

TL;DR Summary
The FDA has approved Omisirge, a cell therapy for patients with blood cancers who are planned for umbilical cord blood transplantation following a myeloablative conditioning regimen. The therapy quickens the recovery of neutrophils and reduces the risk of infection. Omisirge is composed of human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide. The safety and effectiveness of Omisirge was supported by a randomized, multicenter study comparing transplantation of Omisirge to transplantation of umbilical cord blood.
- FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation FDA.gov
- Gamida cell therapy Omisirge for blood cancer FDA approved Seeking Alpha
- Struggling Gamida wins long-awaited FDA approval for Omisirge FiercePharma
- FDA OKs Cell Therapy to Lower Infection Risk After Stem Cell Transplant Medpage Today
- FDA Approves Omisirge to Reduce Infection Risk in Patients With Blood Cancer Curetoday.com
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