FDA rejection

Warning Letter FDA Warning Letter FDA

Biotech

FDA chides Applied Therapeutics' trial conduct in warning letter

While Applied Therapeutics plans to appeal a recent rejection of govorestat, issues with the biotech’s clinical conduct could hamper those plans.

Fraiser Kansteiner Dec 4, 2024 11:21am

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Lykos caps off chaotic week by cutting 75% of staff

Aug 15, 2024 3:59pm

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

Aug 10, 2024 9:07am

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

Feb 27, 2024 9:34am

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With FDA rejection for eye drug, Aldeyra plans speedy new trial

Nov 28, 2023 4:30am

FDA

FDA reverses rejection of Vivos mouthpiece for sleep apnea

Jan 4, 2023 11:12am