After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope left with the FDA

Zachary Brennan

Senior Editor

Back in September 2017, the FDA issued its first complete response letter (CRL) for Intarcia Therapeutics’ lead, type 2 diabetes drug, calling on the company …

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

After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope left with the FDA

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

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

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

RFK Jr. and Elon Musk want to ban pharma ads. They wouldn't be the first to try

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

Af­ter 2 damn­ing CRLs and 3 de­nied dis­pute-res­o­lu­tion re­quests, an ail­ing, one-time uni­corn has on­ly a glim­mer of hope left with the FDA

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

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

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

RFK Jr. and Elon Musk want to ban phar­ma ads. They would­n't be the first to try

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

After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope left with the FDA

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

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

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

RFK Jr. and Elon Musk want to ban pharma ads. They wouldn't be the first to try

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