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On February 9, 2022, Gamida Cell announced that it has initiated rolling submissions to the U.
According to the press release, omidubicel is expected to be the first advanced cell therapy product approved by the U.
Omidubicel is an allogeneic hematopoietic stem cell (bone marrow) transplant solution for the treatment of blood cancer patients
▲The research and development progress of Omidubicel (Image source: Gamida Cell's official website)
References:
[1] Gamida Cell Initiates Rolling Submission of Biologics License Application for Omidubicel.
(Original abridged)