根据制造商葛兰素史克的新闻稿，FDA 已接受首创口服抗生素吉泊汀的新药申请 (NDA)。该药物具有新颖的作用机制，旨在治疗患有无并发症尿路感染(UTI)的女性和青春期女孩。 吉泊汀的 NDA 已获得 FDA 的优先审查，PDUFA 日期为 2025 ...

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

▎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 ...

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

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

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 ...

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

(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 ...

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 ...

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