Herriot Tabuteau, Axsome CEO (Photo by Owen Hoffmann/Patrick McMullan via Getty Images)

August 19, 2022 10:09 AM EDTUpdated 10:21 AM

Following an almost yearlong wait, FDA approves Axsome's rapid-acting depression drug

Kyle LaHucik

Senior Reporter

After a nearly 365-day delay, Axsome Therapeutics has secured its first drug approval with an FDA green light for Auvelity as a treatment for adults …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

Following an almost yearlong wait, FDA approves Axsome's rapid-acting depression drug

Kyle LaHucik

Senior 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?

Fol­low­ing an al­most year­long wait, FDA ap­proves Ax­some's rapid-act­ing de­pres­sion drug

Kyle LaHucik

Senior 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?

Following an almost yearlong wait, FDA approves Axsome's rapid-acting depression drug

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?