Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023.
Gamida Cell announced today that the U.S. FDA has accepted for filing the Company’s biologics license application for omidubicel for the treatment of patients with blood cancers in need of an allogenic haematopoietic stem cell transplant.
