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 ...

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

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

▎药明康德内容团队编辑GSK今天宣布，美国FDA已接受其潜在"first-in-class"口服抗生素gepotidacin的新药申请（NDA），用于治疗患有单纯性尿路感染（uUTI，也称为急性膀胱炎）成年或青少年（≥12岁）女性患者，患者体重须≥4 ...

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 ...

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

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea. In the EAGLE-1 ...

(RTTNews) - GSK plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of action for the treatment of female adults and ...