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U.S. FDA

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
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
Richard Pazdur

FDA's Richard Pazdur explains confirmatory trial rejection, more

Apr 8, 2024 6:00am
Marks

Peter Marks says FDA ready to review novel cancer vaccines

Apr 3, 2024 2:39pm
The Top Line

'The Top Line': Unraveling Alzheimer's disease treatments

Oct 13, 2023 6:00am
Pfizer

Panel of FDA experts endorses Pfizer's RSV vaccine prospect

Feb 28, 2023 4:59pm

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