Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials26 March 2025 assigned as action ...

The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics ...

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 PDUFA target date was set for March 26, 2025. The Food and Drug Administration has granted Priority Review to gepotidacin for the treatment of female adult and adolescent patients aged 12 ...

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 ...

GSK's gepotidacin, an oral antibiotic for uUTIs, could be the first in over 20 years. The FDA granted Priority Review with a ...

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 plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of ...