The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.

One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research ...

The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier this month.

Moderna says the U.S. Food and Drug Administration (FDA) has agreed to review its influenza ‌vaccine, reversing an earlier decision to reject the application, following modifications from the company.

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

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

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 ...

In the latest move by Secretary Robert F. Kennedy, Jr.’s Department of Health and Human Services (HHS) to change the federal government’s stance on vaccines, the Food and Drug Administration (FDA) has ...

The FDA reversed course and told Moderna it would review its application for a new flu vaccine, the company announced Wednesday.

The FDA will review Moderna’s new mRNA flu vaccine after reversing course, raising fresh concerns about potential setbacks ...