FDA's Peter Marks overrode reviewers’ call to reject Sarepta’s new Duchenne gene therapy

Lei Lei Wu

News Reporter

Peter Marks, the senior FDA official who oversees the regulation of gene therapies, overrode agency reviewers’ decision to reject Sarepta Therapeutics’ Duchenne muscular dystrophy gene …

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FDA's Peter Marks overrode reviewers’ call to reject Sarepta’s new Duchenne gene therapy

Lei Lei Wu

News Reporter

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FDA's Pe­ter Marks over­rode re­view­ers’ call to re­ject Sarep­ta’s new Duchenne gene ther­a­py

Lei Lei Wu

News Reporter

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

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FDA's Peter Marks overrode reviewers’ call to reject Sarepta’s new Duchenne gene therapy

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?