drug approvals

FDA

Biotech

FDA plans real-time release of drug rejection letters

Alongside the new policy, the FDA released 89 new complete response letters, adding to the more than 200 that were previously made public in July.

Darren Incorvaia Sep 4, 2025 1:45pm

paper paperclips

Fierce Pharma

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

Jul 11, 2025 10:15am

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