June 27, 2016 10:25 AM EDT

Bristol-Myers’ nivolumab grabs its sixth breakthrough designation as new links to autoimmune diseases creep up

Arsalan Arif

Founder

This morning the FDA handed out its 6th “breakthrough” drug designation for Bristol-Myers Squibb’s Opdivo (nivolumab), signaling once again the agency will continue to …

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Bristol-Myers’ nivolumab grabs its sixth breakthrough designation as new links to autoimmune diseases creep up

Arsalan Arif

Founder

Sign up to read this article for free.

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

Bris­tol-My­ers’ nivolum­ab grabs its sixth break­through des­ig­na­tion as new links to au­toim­mune dis­eases creep up

Arsalan Arif

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

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?

Bristol-Myers’ nivolumab grabs its sixth breakthrough designation as new links to autoimmune diseases creep up

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?