drug approvals

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FDA's response letter salvo sheds light on drug refusal process

The FDA's response letter salvo offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.
Image of a neon sign with the word no lit up next to an unlit yes

FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am
positive negative up down good bad mixed

FDA single-trial guidance calls for the good, bad and ugly data

Sep 19, 2023 10:15am
Illustration of Amyloid plaques around neurons alongside healthy neurons

The FDA's decision on aducanumab will drag down science

Jun 9, 2021 8:45am
stocks

Aducanumab approval appears to boost Biogen's AD competitors

Jun 7, 2021 1:00pm
FDA commissioner Stephen Hahn

New commish, COVID-19, bad comms hitting FDA speedy approvals

Aug 26, 2020 8:40am