FDA AdComm votes 9-0 in favor of mRNA-1010 flu vaccine benefit-risk
An FDA advisory panel voted in favor of Moderna’s mRNA-1010 (mFLUSIVA) for Seasonal influenza prevention in adults 50+ on Jun 18, 2026. The FDA usually follows the panel, but it makes the final call.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Moderna, Inc. MRNA
- Drug
- mRNA-1010 (mFLUSIVA)
- For
- Seasonal influenza prevention in adults 50+
- Stage
- Regulatory (BLA)
- When
- Jun 18, 2026
- Source note
- VRBPAC voted 9-0 that benefits outweigh risks for mRNA-1010 in adults 50-64 and again 9-0 in adults 65 and older. The vote set up the August 5 PDUFA decision.
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- FDA advisory committee calendar ↗
- MRNA headlines on this site
Moderna expects European regulators to decide on mRNA-1010 / mFLUSIVA for Seasonal influenza, adults during 2026 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- mRNA-1010 (mFLUSIVA) ex-US approvals (EU/Canada/Australia) expected to begin · Regulatory approval
- Drug
- mRNA-1010 / mFLUSIVA
- For
- Seasonal influenza, adults
- Stage
- Under regulatory review
- When
- 2026 · the company gave a window, not a day
- Source note
- Moderna Q2 2026 earnings release (Aug 2026). FDA approved mFLUSIVA on Aug 5, 2026 (adults 50+); the Aug 5 approval release reiterates mRNA-1010 is under review in the EU, Canada and Australia with additional submissions planned during 2026.
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- Checked by a person when it was added
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- MRNA headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Moderna expects to report results from its Registrational study (target enrollment reached) study of mRNA-3927 for Propionic acidemia (rare metabolic disease) in the second half of 2026 (no exact date yet). Registrational study (target enrollment reached) is a study designed to support approval.
More details
- Entry
- mRNA-3927 registrational data in propionic acidemia · Clinical trial results (readout / topline data)
- Drug
- mRNA-3927
- For
- Propionic acidemia (rare metabolic disease)
- Stage
- Registrational study (target enrollment reached) · a study designed to support approval
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Moderna Q2 2026 press release: 'Moderna expects potential data in 2026' from the registrational propionic acidemia study; MMA program decision deferred until these data read out.
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- Checked by a person when it was added
- Verify it
- Source: accessnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MRNA headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page