May 12, 2023 06:14 PM EDTUpdated May 15, 07:21 AM

FDA adcomm backs accelerated approval of Sarepta's Duchenne gene therapy in close vote

Lei Lei Wu

News Reporter

An FDA advisory committee voted 8-6 on Friday that the benefits of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy outweigh its risks, lending their …

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FDA adcomm backs accelerated approval of Sarepta's Duchenne gene therapy in close vote

Lei Lei Wu

News Reporter

Sign up to read this article for free.

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FDA ad­comm backs ac­cel­er­at­ed ap­proval of Sarep­ta's Duchenne gene ther­a­py in close vote

Lei Lei Wu

News Reporter

Sign up to read this article for free.

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

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

FDA adcomm backs accelerated approval of Sarepta's Duchenne gene therapy in close vote

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

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