The FDA cited deficiencies in its govorestat’s application in galactosemia, a rare metabolic disease, Applied Therapeutics said. The biotech is still on track to submit a separate application for the drug in sorbitol dehydrogenase (SORD) deficiency, another rare disease that has no FDA-approved therapies.
The post Applied Therapeutics Drug Is Denied FDA Approval in Rare Inherited Metabolic Disease appeared first on MedCity News.
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