Nuzolvence (zoliflodacin)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- zoliflodacin
- Company
- Entasis Therap
- Status
- Approved
- FDA approval
- Fri 12 Dec 2025
- Designations
- New molecular entity, Priority review
- Application
- NDA219491
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 12 Dec 2025🇺🇸 FDA approval
FDA approves Nuzolvence (zoliflodacin), a new medicine
Entasis Therap; NDA219491; New molecular entity, Priority review; for suspension · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.