Approvable designations; Nonapprovable designation; Fast-track designation; Priority review; Orphan drug designations
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FDA Accepts NDA for Zoliflodacin, Potentially First Gonorrhea Antibiotic in Decades
June 13th 2025The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for treating uncomplicated gonorrhea, offering a potential new option amid rising antibiotic resistance.
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