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

Senior Editor

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 …

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER
TRENDING NOW

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

sponsored

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

A service from the Financial Times