STAT Plus: FDA refuses application for cell therapy from Bristol and Bluebird, dealing both a major setback
The Food and Drug Administration refused to even consider an application to approve a new cell therapy for the blood cancer multiple myeloma from Bluebird Bio and Bristol Myers Squibb because the applications lacked details regarding how the product is manufactured, the companies said Wednesday.
That rejection of the cell therapy, which is called idecabtagene vicleucel, or ide-cel, is a major setback for both companies.
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