▎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 ...

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.

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

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

10月16日，国家医保局在官网发布《国家医疗保障局办公室关于规范医保药品外配处方管理的通知》（简称《通知》），旨在加强外配处方的规范管理。这源于近期国家医保局在专项飞行检查发现，一些定点医疗机构和定点零售药店外配医保药品处方管理粗放，存在虚假处方、超 ...

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 announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for gepotidacin, a first-in-class oral antibiotic, under priority review.

Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...

(Alliance News) - GSK PLC on Wednesday announced that the US Food & Drug Administration has accepted its New Drug Application for gepotidacin. The London-based biopharma company said the FDA has ...