Internal documents shed new light on Sarepta FDA decision, which top agency official says was ‘exceptional’

Lei Lei Wu

News Reporter

While he has repeatedly advocated for accelerated gene therapy approvals, the FDA’s top cell and gene therapy official Peter Marks said that the agency’s landmark …

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Internal documents shed new light on Sarepta FDA decision, which top agency official says was ‘exceptional’

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

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

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

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

In­ter­nal doc­u­ments shed new light on Sarep­ta FDA de­ci­sion, which top agency of­fi­cial says was ‘ex­cep­tion­al’

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

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

Com­pound­ed weight loss drugs have re­sult­ed in mis­dos­ing, hos­pi­tal­iza­tions, FDA warns

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

Internal documents shed new light on Sarepta FDA decision, which top agency official says was ‘exceptional’

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

Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns

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