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, ...
▎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 ...
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 ...
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 ...
GSK's gepotidacin, an oral antibiotic for uUTIs, could be the first in over 20 years. The FDA granted Priority Review with a ...
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 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.
(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 ...
Here is what you need to know at the London market open: FTSE 100: opened up 56.75 points, or 0.7%, at 8,306.03 Hang Seng: up 0.3% at 20,371.80 Nikkei 225: closed down 1.8% at 39,180.30 S&P/ASX 200: ...
London open The FTSE 100 is expected to open 17 points higher on Wednesday, having closed down 0.52% on Tuesday at 8,249.28.