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FDA Approves Groundbreaking Stem Cell Therapy for Aplastic Anemia

12/9/2025

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Summary

Story summary

The U.S. FDA approved Omidubicel-onlv (Omisirge) as the first stem cell transplant therapy for severe aplastic anemia patients lacking a compatible donor, announced at the American Society of Hematology annual meeting in Orlando, Florida.
In a study, 95% of patients achieved rapid neutrophil recovery within 8 days, with 94% disease-free and overall survival.
No severe acute or chronic graft-versus-host disease was reported.
Common side effects include febrile neutropenia and infections.

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Story summary

The U.S. FDA approved Omidubicel-onlv (Omisirge) as the first stem cell transplant therapy for severe aplastic anemia patients lacking a compatible donor, announced at the American Society of Hematology annual meeting in Orlando, Florida.
In a study, 95% of patients achieved rapid neutrophil recovery within 8 days, with 94% disease-free and overall survival.
No severe acute or chronic graft-versus-host disease was reported.
Common side effects include febrile neutropenia and infections.