mRNA Vaccine Development

FDA Refuses To Review Moderna’s Flu Vaccine

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 that’s been a target of some Trump administration health officials.

· 15h · on MSN

Moderna shares fall as FDA declines to review new flu vaccine

· 15h · on MSN

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

· 20h

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

The vaccine maker Moderna said on Tuesday that the Food and Drug Administration had notified the company that the agency would not review its mRNA flu vaccine, the latest sign of federal health policy...

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FDA declines to review Moderna application for new flu vaccine

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

BioSpace

Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence

Despite Sanofi CEO Paul Hudson’s confidence in vaccines, the French pharma has cut at least one mRNA flu shot program.

19h

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

The Independent on MSN

First mRNA vaccine to be produced in UK approved

First mRNA vaccine to be produced in UK approved by regulators - The Moderna Innovation and Technology Centre will make millions of cutting-edge mRNA vaccines