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Home » UPDATE 1-US FDA extends review of Applied Therapeutics’ genetic disease drug

UPDATE 1-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. There are currently no approved treatments for the disease in the United States, which has about 3,000 Galactosemia patients. The FDA delayed its decision on the drug, govorestat, saying it requires additional time to review supplemental analyses submitted by the company.

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