FDA rejection

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

The FDA's response letter salvo offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.
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FDA chides Applied Therapeutics' trial conduct in warning letter

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