Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) is a Moderna Inc. program in seasonal influenza in U.S. adults 50 years of age and older. The FDA approved it on Aug 5, 2026. 1 FDA decision on record below. Every date links its source.
FDA approval tracked on pdufa.bio: seasonal influenza in U.S. adults 50 years of age and older (approved Aug 5, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Moderna Inc. (MRNA). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010); 1 FDA decision is on record below.
What happened at MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)'s most recent FDA decision?
On Aug 5, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) used for?
In our records MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) is FDA-approved for seasonal influenza in U.S. adults 50 years of age and older (approved Aug 5, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Who makes MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)?
Moderna Inc. (MRNA).
Has MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) been approved by the FDA?
Yes. The FDA approved an application for MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) on Aug 5, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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