Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) of zoliflodacin, a groundbreaking single-dose oral antibiotic designed to treat uncomplicated gonorrhea in individuals aged 12 and older. This investigational drug, developed in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), could become the first new antibiotic for gonorrhea treatment in decades. The FDA has set a target decision date of December 15, 2025, under the Prescription Drug User-Fee Act (PDUFA). Zoliflodacin has also received a Qualified Infectious Disease Product (QIDP) designation, which provides Priority Review and Extended Market Exclusivity benefits. Entasis Therapeutics, Inc., an affiliate of Innoviva, holds commercial rights for zoliflodacin in major global markets, while GARDP is tasked with registration and commercialization in other regions, particularly in low and middle-income countries.