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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