Applied therapeutics provides fda update on pdufa target action date for govorestat for the treatment of classic galactosemia

New york, march 28, 2024 (globe newswire) -- applied therapeutics, inc. (nasdaq: aplt), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the u.s. food and drug administration (fda) has extended the review period for the new drug application (nda) for govorestat (at-007) for the treatment of classic galactosemia by three months. the fda has set a new prescription drug user fee act (pdufa) target action date of november 28, 2024.
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