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Moderna shares fall

Moderna says FDA refuses its application for new mRNA flu vaccine

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.

· 20h · on MSN

Moderna shares fall as FDA declines to review new flu vaccine

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F.D.A. Refuses to Review Moderna Flu Vaccine

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FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology tha...

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FDA Refuses to Consider Approving Use of Moderna’s New Flu Vaccine

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In rare move, FDA rejects Moderna’s filing for mRNA flu shot

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Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna

17hon MSN

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech company said the FDA won’t review its flu vaccine, in the latest hit to mRNA development.

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FDA refuses Moderna's application for new mRNA flu vaccine

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

Moderna, Mexico Partner To Boost Local Vaccine Production

Moderna signs a long-term deal with Mexico to build local mRNA production, transfer technology, and supply up to 10 million COVID vaccine doses for the 2025–2026 campaign.