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, ...
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 ...
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.