GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review
GSK(GSK) ZACKS·2024-10-18 01:11
GSK plc (GSK) announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational, first-in-class oral antibiotic, gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on March 26, 2025. If approved, gepotidacin could become the first in a new class of oral antibiotic medicines to be approved for treating uUTIs in mor ...