FDA delays decision on Applied Therapeutics’ rare metabolic disease drug
The FDA has pushed back its decision date on Applied Therapeutics’ treatment for classic galactosemia to the end of November, the biotech announced Thursday.
The agency previously set an Aug. 28 deadline for the rare disease drug, called govorestat, but the decision will now come by Nov. 28. According to Applied Therapeutics, the FDA said it needed additional time “to review supplemental analyses of previously submitted data.”
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