FDA rejection

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Biotech

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

Capricor called the rejection "difficult to understand" because the FDA had originally okayed the company's submission plan.

Darren Incorvaia Sep 9, 2025 11:44am

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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

Minerva goddess Rome bust statue knowledge

Minerva's schizophrenia drug rejected by FDA for 2nd time

Feb 27, 2024 9:34am