Applied therapeutics receives complete response letter from u.s. fda regarding new drug application for govorestat for classic galactosemia

New york, nov. 27, 2024 (globe newswire) -- applied therapeutics, inc. (nasdaq: aplt), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the u.s. food and drug administration (fda) has issued a complete response letter (crl) for the new drug application (nda) for govorestat, a novel, central nervous system (cns)-penetrant aldose reductase inhibitor (ari), for the treatment of classic galactosemia.
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