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FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

  • Written by Ana Santos Rutschman, Professor of Law, Villanova University
FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the lawIn December 2025, Moderna submitted an application to the FDA to approve the first mRNA-based flu vaccine.Catherine Falls Commercial/Moment via Getty Images

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine.

The agency’s decision, which Moderna announced...

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