FDA accepts for priority review application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)

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FDA has accepted the Biologics License Application for idecabtagene vicleucel (ide-cel; bb2121) as Priority Review.

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In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 

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