May 18, 2023 02:05 PM EDT

CDER leaders ready to implement swifter accelerated approval withdrawal process

Zachary Brennan

Senior Editor

With the long Makena accelerated approval withdrawal saga fresh in their minds, both the director of the FDA’s Center for Drug Evaluation and Research …

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CDER leaders ready to implement swifter accelerated approval withdrawal process

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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ADSTILADRIN® (nadofaragene firadenovec-vncg) – A Growing Body of Clinical Data and Real-World Evidence

CDER lead­ers ready to im­ple­ment swifter ac­cel­er­at­ed ap­proval with­draw­al process

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Makary, in one of first com­ments on FDA pol­i­cy, floats new path­way for rare dis­ease drugs

Chi­na start­up in­jects CRISPR ther­a­py in­to the brain for the first time

Trodelvy and Keytru­da com­bo suc­ceeds in Phase 3 breast can­cer study

Roivant brings rare dis­ease pro­gram clos­er as Im­muno­vant CEO re­tires

FDA plans to ban phar­ma em­ploy­ees from serv­ing on ad­comms. The im­pact will be lim­it­ed

AD­STI­LADRIN® (nad­o­fara­gene fi­rade­n­ovec-vncg) – A Grow­ing Body of Clin­i­cal Da­ta and Re­al-World Ev­i­dence

CDER leaders ready to implement swifter accelerated approval withdrawal process

Makary, in one of first comments on FDA policy, floats new pathway for rare disease drugs

China startup injects CRISPR therapy into the brain for the first time

Trodelvy and Keytruda combo succeeds in Phase 3 breast cancer study

Roivant brings rare disease program closer as Immunovant CEO retires

FDA plans to ban pharma employees from serving on adcomms. The impact will be limited

ADSTILADRIN® (nadofaragene firadenovec-vncg) – A Growing Body of Clinical Data and Real-World Evidence