06/10/2025 10:00
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approv...