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Moderna, Senior FDA

Moderna says FDA refuses to review its application for experimental flu shot

The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company said.

· 8h · on MSN

FDA Refuses to Review Moderna’s New Flu Shot

Opinion

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Moderna Has a Promising New Flu mRNA Vaccine. Trump’s FDA Wants Nothing to Do With It

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FDA defends its decision to refuse review of Moderna's flu vaccine

Shares of Moderna (MRNA.O) slumped nearly 9% in premarket trading on Wednesday after the U.S. Food and Drug Administration declined to review the company's application for approval of its experimental...

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

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Moderna says FDA won't review its mRNA flu shot | Morning in America

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FDA Refuses to Review Moderna's mRNA Flu Shot

In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine.

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

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Moderna shares drop after FDA refuses to file for mRNA-1010 influenza vaccine

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

Seeking Alpha

Moderna Announces Data to be Presented at the 2025 International Congress of Inborn Errors of Metabolism

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of ...

The National Law Review

Moderna Announces Data to be Presented at ESMO Congress 2025

CAMBRIDGE, MA / ACCESS Newswire / July 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that three abstracts on its investigational mRNA therapeutics have been accepted for presentation at the 2025 European Society for Medical Oncology (ESMO ...