US FDA extends review of Applied Therapeutics' genetic disease drug
28/03/2024 20:42
March 28 (Reuters) - The U.S. Food and Drug
Administration has extended its review of Applied Therapeutics'
APLT.O 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)
((Mariam.ESunny@thomsonreuters.com;))