October 28, 2022 03:33 PM EDTUpdated 03:48 PM

Citing too many data confounders, FDA adcomm unanimously votes against Y-mAbs' drug for rare brain cancer

Lei Lei Wu

News Reporter

On Friday afternoon, the FDA’s oncology drug advisory committee unanimously voted 16-0 against the approval of Y-mAbs’ experimental drug for CNS metastases in pediatric neuroblastoma …

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Citing too many data confounders, FDA adcomm unanimously votes against Y-mAbs' drug for rare brain cancer

Lei Lei Wu

News Reporter

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

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Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?

Cit­ing too many da­ta con­founders, FDA ad­comm unan­i­mous­ly votes against Y-mAb­s' drug for rare brain can­cer

Lei Lei Wu

News Reporter

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?

Citing too many data confounders, FDA adcomm unanimously votes against Y-mAbs' drug for rare brain cancer

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?