FDA rejection

end of the road road block shut down closed blocked

Biotech

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Sentynl and Cyprium were angling the drug candidate to be the first approved treatment for a rare, often fatal pediatric disease.

Zoey Becker Oct 1, 2025 12:00pm

Manila folder with CONFIDENTIAL printed on it in red

Capricor responds to cell therapy snub, disputes FDA’s concerns

Sep 9, 2025 11:44am

paper paperclips

Fierce Pharma

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

Jul 11, 2025 10:15am

Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am

A young woman cutting Rose flowers in the garden

Lykos caps off chaotic week by cutting 75% of staff

Aug 15, 2024 3:59pm

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