U.S. FDA

FDA
Favicon Fierce Pharma

FDA investigates 2 deaths after Sarepta Duchenne gene therapy

The agency is investigating two Duchenne muscular dystrophy patient deaths following treatment with Sarepta Therapeutics’ Elevidys.
Angus Liu Jun 25, 2025 10:26am
cancer target detection radiopharma radio

Nuvalent trots out strong pivotal data in FDA lung cancer push

Jun 24, 2025 6:30am
China

China proposal would match US clinical trial review times

Jun 16, 2025 5:30pm
Redbrick building with Sarepta name and logo
Favicon Fierce Pharma

2nd patient dies after Sarepta's DMD gene therapy Elevidys

Jun 16, 2025 10:58am
Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am
Image of a neon sign with the word no lit up next to an unlit yes

Lykos' MDMA treatment for PTSD has been quashed at the FDA

Aug 10, 2024 9:07am