Regulatory update on govorestat for the treatment of classic galactosemia
Applied Therapeutics, Inc. a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced an update on the ongoing New Drug Application (NDA) review of govorestat for the treatment of Classic Galactosemia
The Company recently completed its late-cycle review meeting with the FDA . The FDA communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024. The FDA informed the Company that the Priority Review of the NDA is continuing as planned with alignment on post-marketing requirements expected in October 2024. The previously announced Prescription Drug User Fee Act (PDUFA) target action date remains on track for November 28, 2024
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