FDA pushes back Gamida Cell’s PDUFA date by three months

cafead

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  • cafead   Nov 27, 2022 at 07:32: PM
via Boston-based biotech Gamida Cell will have to wait on the FDA for a little while longer.

The biotech said that in the BLA review for its allogeneic hematopoietic stem cell transplant, called omidubicel, the FDA issued an “information request” and views the data in the response as a major amendment.

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