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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.
NEW YORK, March 28, 2024 -- Applied Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications...
Yuma County received seven Major Amendment requests, which doesn't happen every year.
FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023STAMFORD, Conn., June 05, 2023 -- SpringWorks Therapeutics, Inc. , a... | June 5, 2023
Growth of VOXZOGO® Accelerated with Rapid Uptake in Japan and Brazil Resulting in Increased Full-year 2023 GuidanceFull-year 2023 Top-line and Bot...