# MRNA PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRNA
Company: Moderna, Inc.

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

## MRNA PDUFA Milestones

- 2024-05-31 — FDA Approval — FDA approved application. FDA recorded approval of mRESVIA (mRNA-1345) on May 31, 2024. This list-only historical record is sourced from the official FDA app...
  Company: Moderna, Inc.
  Source: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2024-biological-license-application-approvals
  Event detail: https://biopharmsignal.com/pdufa-calendar/MRNA/mresvia-mrna-1345-mresvia-bla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/may (May 2024)
- 2025-05-30 — FDA Approval — FDA approved application. FDA recorded approval of mNEXSPIKE (mRNA-1283) on May 30, 2025. This list-only historical record is sourced from the official FDA a...
  Company: Moderna, Inc.
  Source: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2025-biological-license-application-approvals
  Event detail: https://biopharmsignal.com/pdufa-calendar/MRNA/mnexspike-mrna-1283-mnexspike-bla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025)
- 2025-06-12 — FDA Approval — FDA approved application. FDA recorded approval of mRESVIA on June 12, 2025. This list-only historical record is sourced from the official FDA application da...
  Company: Moderna, Inc.
  Source: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2025-biological-license-application-supplement-noteworthy-approvals
  Event detail: https://biopharmsignal.com/pdufa-calendar/MRNA/mresvia-mresvia-younger-adults-sbla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025)
- 2026-08-05 — PDUFA — FDA approved mFLUSIVA for adults aged 50 and older. FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and ol...
  Company: Moderna, Inc.
  Source: https://investors.modernatx.com/news/news-details/2026/Moderna-Receives-U-S--FDA-Approval-for-Influenza-Vaccine-mFLUSIVA/default.aspx
  Event detail: https://biopharmsignal.com/pdufa-calendar/MRNA/mrna-1010-influenza.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)

## Related Pages

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

## FAQ

### What does the MRNA PDUFA calendar show?

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

Use the BioPharmSignal company page for MRNA 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.