FDA rais­es big safe­ty is­sues in No­var­tis’ CAR-T re­view, but spot­lights post-mar­ket­ing path for­ward

The FDA’s in-house re­view of No­var­tis’ ground­break­ing CAR-T ther­a­py ti­s­agen­le­cleu­cel (CTL019) came out this morn­ing, care­ful­ly out­lin­ing the ef­fi­ca­cy tracked in Phase II and hon­ing …

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