Gamida Cell provides regulatory update on omidubicel

Gamida Cell

21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months.

Gamida Cell today provided an update on recent interactions with the U.S. Food and Drug Administration (FDA) relating to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant.

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Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier