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• The FDA has approved omidubicel for patients with blood cancers requiring allogeneic hematopoietic stem cell transplant (HSCT). • A phase 3 trial showed omidubicel significantly reduced the median time to neutrophil engraftment compared to standard umbilical cord blood (UCB) grafts. • Omidubicel offers a new option for stem cell source, potentially improving outcomes for patients ineligible for traditional transplants. • The approval underscores the FDA's commitment to innovative therapies for life-threatening cancers, providing a new treatment option.