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New Confirmatory Study Suggests Progress in Applied Therapeutics–FDA Alignment for Rare Disease Drug
Applied Therapeutics; govorestat; CMT-SORD; rare disease; FDA; confirmatory study; clinical trial; regulatory alignment
Applied Therapeutics’ Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection
Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter