gepotidacin, FDA and GSK
FDA set to decide on GSK's gepotidacin antibiotic in March
The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 years. The US regulator is scheduled to deliver a decision on the marketing application by 26th March next year, said GSK in a statement.
GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review
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 urinary tract infections (uUTIs) in female adults and adolescents.
Gepotidacin Gets Priority Review for Uncomplicated UTI in Female Patients
The FDA granted Priority Review to gepotidacin for the treatment of female adults and adolescents with uncomplicated UTI.
Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents
Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials26 March 2025 assigned as action date for FDA decisionGepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years  GSK plc
GSK Plc: NDA For Gepotidacin Granted Priority Review By FDA - Quick Facts
GSK plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of
GSK UTI treatment gets FDA priority review status
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.
GSK: FDA Accepts New Drug Application for Gepotidacin
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US FDA accepts for priority review GSK’s NDA for gepotidacin to treat uncomplicated urinary tract infections in female adults and adolescents
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
GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
GSK's gepotidacin, an oral antibiotic for uUTIs, could be the first in over 20 years. The FDA granted Priority Review with a ...
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GSK reports positive data from trial of gonorrhoea antibiotic
UK-based pharmaceutical company GSK has announced positive headline data from the EAGLE-1 Phase III clinical trial of gepotidacin. Gepotidacin is an oral bactericidal antibiotic designed to treat ...
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GSK reveals data on novel gonorrhoea drug gepotidacin
GSK has unveiled the data for its novel antibiotic gepotidacin as a treatment for gonorrhoea, putting the drug on track to become an important therapy for people with resistant forms of the ...
有望成为20年来首款！GSK潜在"first-in-class"小分子疗法获FDA优先审评资格
▎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 ...
PharmiWeb5d
GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024
New data to be shared on GSK’s RSV vaccine across different age groups of patients at increased risk • Efficacy data for gepotidacin in ...