May 17, 2023 02:23 PM EDTUpdated May 17, 09:35 PM

Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs

Nicole DeFeudis

Editor

The FDA has once again raised safety concerns around the use of Intercept’s obeticholic acid in NASH, concluding in briefing documents ahead of an upcoming …

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Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs

Nicole DeFeudis

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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In­ter­cep­t's NASH hope­ful gets pre­lim­i­nary thumbs down in FDA brief­ing docs

Nicole DeFeudis

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?

Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs

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?