Govorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024 Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision...
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...
LONDON, March 28 (Reuters) - European governments are weighing the introduction of tougher rules on cigarette makers' new zero-tobacco heat sticks, moving to close the loopholes they were designed to exploit just months after their launch.
PDUFA target action date of August 28, 2024 MAA validated and accepted for review by EMA in December 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a...
Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in...
NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term...
NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
EMA Orphan Designation reflects high unmet need in SORD Deficiency and benefit of govorestat treatment in reducing toxic sorbitol levelsNew data published in Journal of Clinical Investigation further...
The European Medicines Agency (EMA) has granted orphan medicinal product designation to Applied Therapeutics’ AT-007 (gavorestat) to treat Galactosemia (Galactosaemia).