May 19, 2023 05:03 PM EDTUpdated May 22, 07:21 AM

Updated: In another blow for NASH, FDA adcomm opposes accelerated approval of Intercept drug

Nicole DeFeudis

Editor

An FDA advisory committee on Friday voted against recommending accelerated approval of Intercept’s once-rejected NASH hopeful obeticholic acid, saying the risk-benefit profile didn’t stack up …

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Updated: In another blow for NASH, FDA adcomm opposes accelerated approval of Intercept drug

Nicole DeFeudis

Editor

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

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Up­dat­ed: In an­oth­er blow for NASH, FDA ad­comm op­pos­es ac­cel­er­at­ed ap­proval of In­ter­cept drug

Nicole DeFeudis

Editor

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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?

Updated: In another blow for NASH, FDA adcomm opposes accelerated approval of Intercept drug

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?