Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review | app

BOSTON–(BUSINESS WIRE)–August 1, 2022–

Gamida Cell Ltd. (Nasdaq: GMDA), the leader in developing NAM cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) Unis has agreed to file the Company’s Biologics License Application (BLA) for omibidicel for the treatment of patients with blood cancers requiring allogeneic hematopoietic stem cell transplantation. Omidubicel is a first-in-class, advanced NAM stem cell therapy candidate with breakthrough and orphan drug designations.

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