February 13, 2024 01:37 PM EST

FDA delays PDUFA date for Rocket’s rare white blood cell disorder gene therapy

Anna Brown

News Reporter

The FDA’s decision on Rocket Pharmaceuticals’ autologous gene therapy for a rare white blood cell disorder has been pushed back by three months to June …

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FDA delays PDUFA date for Rocket’s rare white blood cell disorder gene therapy

Anna Brown

News Reporter

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FDA de­lays PDU­FA date for Rock­et’s rare white blood cell dis­or­der gene ther­a­py

Anna Brown

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

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FDA delays PDUFA date for Rocket’s rare white blood cell disorder gene therapy

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?