April 27, 2023 03:47 PM EDT

FDA to review Takeda's BLA resubmission for subcutaneous UC drug Entyvio after 2019 rejection

Katherine Lewin

News Reporter

Takeda has refiled a biologics license application for its subcutaneous version of the blockbuster ulcerative colitis drug Entyvio following an FDA rejection in 2019, the …

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FDA to review Takeda's BLA resubmission for subcutaneous UC drug Entyvio after 2019 rejection

Katherine Lewin

News Reporter

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FDA to re­view Takeda's BLA re­sub­mis­sion for sub­cu­ta­neous UC drug En­tyvio af­ter 2019 re­jec­tion

Katherine Lewin

News Reporter

Sign up to read this article for free.

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

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

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

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

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

FDA to review Takeda's BLA resubmission for subcutaneous UC drug Entyvio after 2019 rejection

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

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

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

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

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