Applied Therapeutics

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Biotech

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

CEO Shoshana Shendelman, Ph.D., was named in a recent lawsuit along with the company's chief medical officer and the biotech itself.

Darren Incorvaia Dec 20, 2024 12:51pm

Gavel on top of dollars

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

delay FDA delay

Applied Tx’s pediatric rare disease prosect hits another snag

Mar 29, 2024 10:21am