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 adolescents with uncomplicated urinary tract infections. The FDA has granted Priority Review and assigned a PDUFA action date of 26 March 2025. The NDA is supported by positive results from the phase III EAGLE-2 and EAGLE-3 trials.
The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.