October 27, 2021 11:40 AM EDT

FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing

Zachary Brennan

Senior Editor

The once never-ending rise of breakthrough designation requests at the FDA slowed again in 2021, with just over 100 requests coming into the agency, compared …

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FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing

Zachary Brennan

Senior Editor

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FDA+ roundup: CDER's break­through des­ig­na­tion re­quests see steep de­cline in 2021; Drug­mak­ers call to ex­pand FDA guid­ance on PD-(L)1 dos­ing

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?

FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing

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?