Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission

Zachary Brennan

Senior Editor

When Congress punted on adding new accelerated approval reforms to the user fee legislation, many wondered how and when the agency would get around to …

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Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission

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

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?

Start­ing with ADC, FDA calls for ful­ly en­rolled con­fir­ma­to­ry tri­al pri­or to ac­cel­er­at­ed ap­proval sub­mis­sion

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

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?

Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission

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

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?