The clinical-stage pharmaceutical company said Friday that the Food and Drug Administration has approved its new drug application for Orlynvah as a treatment for uncomplicated urinary tract infections caused by certain microorganisms in adult women with limited or no alternative oral antibacterial treatment options.

This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum. "We are so pleased to have achieved this historic milestone and would like to thank all the patients,