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

GSK plc GSK announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational, ...

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

The FDA granted Priority Review to gepotidacin for the treatment of female adults and adolescents with uncomplicated UTI.

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

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

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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 ...

On Wednesday, the FDA accepted GSK plc’s (NYSE:GSK) marketing application seeking approval for gepotidacin, an investigational, oral antibiotic for adult and adolescent females with ...

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 ...