FDA approves Moderna's mRNA flu vaccine
FDA approves Moderna's mRNA flu vaccine
Moderna
Moderna is a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines. The company develops mRNA medicines for infectious diseases, cancer, rare diseases, and autoimmune conditions, with the first commercial product (Spikevax COVID-19 vaccine) approved in 2020 and ongoing development of seasonal flu, RSV, and oncology programs.
Company Info
Sector:RNA, Peptide & Gene Therapy
Headquarters:Cambridge, Massachusetts, USA
Founded:2010
Website:www.modernatx.com/
Upcoming Milestones & Key Dates
2026-06-18
Regulatory
FDA VRBPAC adcomm for mRNA-1010 seasonal flu vaccine
2026 H2
Clinical readout
Phase 3 mRNA-4157 + Keytruda IMpowerLung3 readout in NSCLC
Clinical Development Pipeline
mRNA-1010
Target: Quadrivalent mRNA flu vaccinemRNA-4157 (V940) + Keytruda
Target: Personalized neoantigen mRNA cancer vaccine + pembrolizumabmRNA-1345 (mRESVIA)
Target: Stabilized prefusion F protein mRNARecent News
US FDA approves first mRNA flu shot from Moderna, includes gallery
US FDA approves first mRNA flu shot from Moderna, includes gallery
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Moderna's mRNA flu shot has won FDA approval, bouncing back after a refusal-to-file letter earlier this year and becoming the first approved mRNA flu vaccine.
Moderna delays norovirus vaccine trial readout because of too few infections
Moderna is delaying the readout of its norovirus vaccine trial because the study has not yet accumulated enough infections to power the analysis.
Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain
Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain
Moderna beats quarterly revenue estimates ahead of key US flu vaccine decision
Moderna beats quarterly revenue estimates ahead of key US flu vaccine decision
Moderna adds commercial chief, expands Stephen Hoge's role; Reunion Neuroscience CEO departs
Moderna adds commercial chief, expands Stephen Hoge's role; Reunion Neuroscience CEO departs — Endpoints News coverage of biopharma industry developments.
Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
FDA committee recommends a new mRNA flu vaccine
FDA advisory committee unanimously recommended Moderna's new mRNA influenza vaccine (mFlusiva) for adults 50 and over.
FDA vaccine advisors back Moderna's flu vaccine, bucking past FDA leadership
FDA vaccine advisors unanimously backed Moderna's flu vaccine, a departure from the prior FDA leadership's stance.
Moderna's mRNA flu vaccine backed by FDA advisers
Moderna's mRNA flu vaccine backed by FDA advisers. (Reuters Biopharma.)
Moderna's FDA adcomm, IPO mania, biopharma layoffs, more
Weekly roundup: Moderna's mRNA flu shot heads to adcomm, IPO activity is picking up, and biopharma layoffs continue across multiple companies.
FDA, Moderna appear aligned on mRNA flu shot heading into adcomm
The FDA's Vaccines and Related Biological Products Advisory Committee meets June 18 to discuss Moderna's seasonal flu vaccine mRNA-1010 after the agency initially refused to accept the application in February.
Steeling for new launches, Moderna hires Novartis vet as new CCO
Moderna has hired Ester Banque, a longtime Novartis commercial leader, as its new Chief Commercial Officer to prepare for upcoming product launches including the seasonal flu vaccine mRNA-1010.
Leadership Team
Stéphane Bancel
Chief Executive Officer
James M. Mock Jr.
Chief Financial Officer
Ester Banque
Chief Commercial Officer (joined June 2026)
Careers & Job Openings