MRNA · News · 20260731N
Regulatory Approval Milestones
Moderna, Inc. · 2026-07-31 · Importance 47 · Surprise 60 · In source text
Moderna is awaiting a potential U.S. Food and Drug Administration decision on mFLUSIVA, its seasonal influenza vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date is August 5, 2026. Approval would make mFLUSIVA Moderna’s fifth approved product and support its strategy of diversifying beyond COVID-19 vaccines.
Key facts
- Moderna anticipated a potential approval with an August 5th PDUFA date for mFLUSIVA, its seasonal influenza vaccine candidate. source
- Stock Titan reported Moderna's mFLUSIVA could become its fifth approved product if approved. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | Moderna anticipated a potential approval with an August 5th PDUFA date for mFLUSIVA, its seasonal influenza vaccine candidate. |