US FDA extends review of Applied Therapeutics’ genetic disease drug

By Thomson Reuters Mar 28, 2024 | 3:52 PM

(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)