October 10, 2017 07:14 AM EDTUpdated May 26, 08:50 PM

Spark Therapeutics faces a grilling as FDA ponders a pioneering OK for gene therapy

John Carroll

Editor & Founder

With one of the most closely-watched FDA panel reviews of the year coming up for Spark Therapeutics’ $ONCE lead gene therapy, internal reviewers at the …

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Spark Therapeutics faces a grilling as FDA ponders a pioneering OK for gene therapy

John Carroll

Editor & Founder

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

Spark Ther­a­peu­tics faces a grilling as FDA pon­ders a pi­o­neer­ing OK for gene ther­a­py

John Carroll

Editor & Founder

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?

Spark Therapeutics faces a grilling as FDA ponders a pioneering OK for 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

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?