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FDA Presses Delay Button For Applied Therapeutics First Potential Marketed Drug For Rare Disease - Applied Therapeutics (NASDAQ:APLT) : vimarsana.com
FDA Presses Delay Button For Applied Therapeutics' First Potential Marketed Drug For Rare Disease - Applied Therapeutics (NASDAQ:APLT)
FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.
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