Published 1 month ago

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia - Applied Therapeutics (NASDAQ:APLT)

Summary by Benzinga

NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galacto…

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Benzinga

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia - Applied Therapeutics (NASDAQ:APLT)

1 month ago·New York, United States

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The Straits Times

US FDA extends review of Applied Therapeutics' genetic disease drug

The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday. Read more at straitstimes.com.

1 month ago·Singapore

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WTVB

US FDA extends review of Applied Therapeutics’ genetic disease drug

(Reuters) – The U.S. Food and Drug Administration has extended its review of Applied Therapeutics’ experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday. The health regulator will now give its decision by Nov. 28, 2024, compared with its previous action date of Aug. 28. (Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)

1 month ago

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