March 8, 2023 03:00 PM ESTUpdated 04:03 PM

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

Paul Schloesser

Associate Editor

An FDA advisory committee is meeting on Thursday to weigh a potential label expansion for Roche’s potential blockbuster Polivy, but the agency has some concerns …

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FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

Paul Schloesser

Associate Editor

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FDA rais­es ques­tions in ad­comm brief­ing docs for Roche's Po­livy la­bel ex­pan­sion

Paul Schloesser

Associate 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?

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

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?