FDA reverses course, will review Moderna’s mRNA flu vaccine candidate

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

European health agency recommends approving Moderna’s combined flu, COVID vaccine

The European Medicines Agency (EMA) announced Friday it has recommended Moderna’s combined mRNA COVID-19 and flu vaccine be ...

Moderna says the FDA will consider its new flu shot after resolving a public dispute

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.
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Moderna’s mRNA Flu Vaccine Back Under FDA Review

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

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 ...

FDA declines to review Moderna’s new flu vaccine

The FDA rarely refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions. Moderna has requested an urgent ...

FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine

Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.