The FDA granted Priority Review to gepotidacin for the treatment of female adults and adolescents with uncomplicated UTI.
The FDA accepts and grants priority review to GSK's NDA for gepotidacin for treating uncomplicated urinary tract infections. A decision is due on March 26, 2025.
The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 years.
On Wednesday, the FDA accepted GSK plc’s (NYSE:GSK) marketing application seeking approval for gepotidacin, an ...
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 ...
US FDA accepts for priority review GSK’s NDA for gepotidacin to treat uncomplicated urinary tract infections in female adults and adolescents: London, UK Thursday, October 17, 2 ...
GSK’s new drug application for its investigational oral antibiotic gepotidacin has been accepted for priority review by the ...