October 5, 2023 03:29 PM EDTUpdated 04:18 PM

FDA's oncology adcomm votes against Amgen's confirmatory data for Lumakras in certain types of NSCLC

Zachary Brennan

Senior Editor

The FDA and its oncology advisory committee raised lots of questions on whether Amgen’s confirmatory trial is enough to convert an accelerated approval to a …

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FDA's oncology adcomm votes against Amgen's confirmatory data for Lumakras in certain types of NSCLC

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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FDA's on­col­o­gy ad­comm votes against Am­gen's con­fir­ma­to­ry da­ta for Lumakras in cer­tain types of NSCLC

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

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

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

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's oncology adcomm votes against Amgen's confirmatory data for Lumakras in certain types of NSCLC

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

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

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

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?