drug approvals

FDA
Favicon Fierce Pharma

FDA approves leucovorin without clinical trial—but not for autism

The FDA has used real-world data to approve leucovorin to treat cerebral folate deficiency in patients who have a confirmed variant in the FOLR1 gene.
Angus Liu , Darren Incorvaia Mar 10, 2026 9:00am
FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm
paper paperclips
Favicon 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