# JAZZ PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/JAZZ
Company: Jazz Pharmaceuticals

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with JAZZ.

## JAZZ PDUFA Milestones

- 2024-11-20 — FDA Approval — FDA approved application. FDA recorded approval of ZIIHERA on November 20, 2024. This list-only historical record is sourced from the official FDA applicatio...
  Company: Jazz Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761416
  Event detail: https://biopharmsignal.com/pdufa-calendar/JAZZ/ziihera-bla-761416-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/november (November 2024)
- 2025-08-06 — FDA Approval — FDA approved application. FDA recorded approval of MODEYSO on August 6, 2025. This list-only historical record is sourced from the official FDA application d...
  Company: Jazz Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219876
  Event detail: https://biopharmsignal.com/pdufa-calendar/JAZZ/modeyso-nda-219876-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/august (August 2025)
- 2026-01-27 — FDA Approval — FDA approved application. FDA recorded approval of VYXEOS on January 27, 2026. This list-only historical record is sourced from the official FDA application...
  Company: Jazz Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209401
  Event detail: https://biopharmsignal.com/pdufa-calendar/JAZZ/vyxeos-nda-209401-suppl-18.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/january (January 2026)
- 2026-08-25 — PDUFA — FDA approved two first-line ZIIHERA regimens. FDA approved ZIIHERA with fluoropyrimidine- and platinum-containing chemotherapy plus TEVIMBRA for adults with...
  Company: Jazz Pharmaceuticals
  Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction
  Event detail: https://biopharmsignal.com/pdufa-calendar/JAZZ/zanidatamab-combinations-her2-positive-gea.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/JAZZ
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the JAZZ PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with JAZZ, including decision dates, application stage, and summary details when available.
### Where can I find more context for JAZZ?

Use the BioPharmSignal company page for JAZZ to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.