Roche, Bristol Myers, and Merck prep defense for 6 ‘dangling’ PD-(L)1 accelerated approvals, even though they failed confirmatory trials

Zachary Brennan

Senior Editor

Should 6 significant accelerated approvals for 3 of the top PD-(L)1s on the market get yanked or stand unchanged, even though they failed key required …

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

Roche, Bristol Myers, and Merck prep defense for 6 ‘dangling’ PD-(L)1 accelerated approvals, even though they failed confirmatory trials

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Trump names Johns Hopkins researcher Marty Makary to lead the FDA; also names CDC, Surgeon General picks

FDA approves BridgeBio's heart disease drug, setting up competition with Pfizer, Alnylam

Drug or biologic? An Eli Lilly lawsuit could impact weight loss drug compounders

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

Patient dies in Neurogene's Rett syndrome study

Are programs with compounded GLP-1s safe for your population?

Roche, Bris­tol My­ers, and Mer­ck prep de­fense for 6 ‘dan­gling’ PD-(L)1 ac­cel­er­at­ed ap­provals, even though they failed con­fir­ma­to­ry tri­als

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Trump names Johns Hop­kins re­searcher Mar­ty Makary to lead the FDA; al­so names CDC, Sur­geon Gen­er­al picks

FDA ap­proves Bridge­Bio's heart dis­ease drug, set­ting up com­pe­ti­tion with Pfiz­er, Al­ny­lam

Drug or bi­o­log­ic? An Eli Lil­ly law­suit could im­pact weight loss drug com­pounders

Sur­round­ed by AI bio gi­ants, tiny start­up Nabla Bio makes de no­vo an­ti­bod­ies look more like drugs

Pa­tient dies in Neu­ro­gene's Rett syn­drome study

Are pro­grams with com­pound­ed GLP-1s safe for your pop­u­la­tion?

Roche, Bristol Myers, and Merck prep defense for 6 ‘dangling’ PD-(L)1 accelerated approvals, even though they failed confirmatory trials

Trump names Johns Hopkins researcher Marty Makary to lead the FDA; also names CDC, Surgeon General picks

FDA approves BridgeBio's heart disease drug, setting up competition with Pfizer, Alnylam

Drug or biologic? An Eli Lilly lawsuit could impact weight loss drug compounders

Surrounded by AI bio giants, tiny startup Nabla Bio makes de novo antibodies look more like drugs

Patient dies in Neurogene's Rett syndrome study

Are programs with compounded GLP-1s safe for your population?