May 19, 2021 06:26 AM EDT
Cell/Gene Tx
FDA+

CMC holdup de­lays Io­vance fil­ing again — to 2022 — as FDA seeks more as­say da­ta for TIL ther­a­py

Amber Tong

Re­mem­ber those po­ten­cy as­says that tripped up Io­vance’s prepa­ra­tions for a BLA fil­ing? It turns out they may take even longer than ex­pect­ed to …

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