Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zoliflodacin, marking a significant milestone in the regulatory review process. Zoliflodacin is a first-in-class oral antibiotic aimed at treating uncomplicated gonorrhea in adults, including infections caused by multidrug-resistant strains. The acceptance of the NDA represents a crucial step forward in addressing the growing threat of drug-resistant gonorrhea, a public health concern that has been exacerbated by recent cases of ceftriaxone-resistant infections. If approved, zoliflodacin would be the first new antibiotic treatment for gonorrhea in decades. The Global Antibiotic Research Development Partnership (GARDP) also plays a vital role in this initiative, highlighting the importance of public-private partnerships in combating global antimicrobial resistance.