January 11, 2024 01:01 PM EST

FDA develops pilot to harmonize international gene therapy regulations

Lia DeGroot

The FDA is setting out to streamline international regulations of gene therapies with a pilot program to review applications alongside global regulatory partners, an agency …

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FDA develops pilot to harmonize international gene therapy regulations

Lia DeGroot

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?

FDA de­vel­ops pi­lot to har­mo­nize in­ter­na­tion­al gene ther­a­py reg­u­la­tions

Lia DeGroot

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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?

FDA develops pilot to harmonize international gene therapy regulations

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?