May 28, 2024 03:17 PM EDTUpdated 03:29 PM

FDA details new 'platform technology' process that could accelerate cell and gene therapy approvals

Zachary Brennan

Senior Editor

The FDA on Tuesday released a long-awaited draft guidance explaining how companies can win designations for platform technologies, a regulatory step that could speed up …

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FDA details new 'platform technology' process that could accelerate cell and gene therapy approvals

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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

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

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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 de­tails new 'plat­form tech­nol­o­gy' process that could ac­cel­er­ate cell and gene ther­a­py ap­provals

Zachary Brennan

Senior Editor

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 details new 'platform technology' process that could accelerate cell and gene therapy approvals

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?