Gilead's Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of

Gilead's Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of "Risks Of Secondary Cancer'

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Tuesday, the FDA announced to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies. “We consider this information to be “new safety information” as defined in section 505-1(b)(3) of the FDCA. Furthermore, we…

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