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Wednesday, February 28, 2024

Applied Therapeutics: Priority Review of New Drug Application for Galactosemia

 PDUFA target action date of August 28, 2024

MAA validated and accepted for review by EMA in December 2023

https://www.globenewswire.com/news-release/2024/02/28/2836879/0/en/Applied-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Govorestat-for-the-Treatment-of-Classic-Galactosemia.html

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