Omidubicel

The FDA approved omidubicel-onlv, a donor cord blood-based cell therapy, to accelerate neutrophil recovery and reduce the risk for infection among patients with hematologic malignancies undergoing stem cell transplantation.

The FDA granted priority review to omidubicel, an investigational donor-based stem cell therapy for patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation.

A phase 3 trial of omidubicel has shown the graft modality superior to standard umbilical cord blood for bone marrow transplantation in patients with hematologic malignancies, according to topline data released by the agent’s manufacturer.