Abigail Jenkins, Gamida Cell CEO
FDA pushes back Gamida Cell’s PDUFA date by three months
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.
As a result, it has moved the PDUFA date for omidubicel from January 30, 2023, to May 1. The FDA has also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of next year as well.
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