Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the CAR T-cell therapy’s chemistry, manufacturing, and control — a module necessary to ensure treatment safety, quality, and potency — which were requested by the agency in May in response to the original…
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