Applied Therapeutics

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Biotech

Applied's rare disease drug suffers another phase 3 failure

Applied’s rare disease drug has failed another late-stage clinical trial, adding to the woes of a candidate rejected by the FDA five months ago.

James Waldron May 19, 2025 7:20am

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Applied CEO steps down in wake of FDA rejection, warning letter

Dec 20, 2024 12:51pm

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Lawsuit alleges Applied misled investors before FDA rejection

Dec 19, 2024 7:34am

Warning Letter FDA Warning Letter FDA

FDA chides Applied Therapeutics' trial conduct in warning letter

Dec 4, 2024 11:21am

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FDA rejects Applied filing for rare disease approval

Dec 2, 2024 5:27am

FDA

FDA scraps adcomm for Applied's rare disease drug

Sep 18, 2024 8:00am