Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused to do so. The post FDA to review Moderna's mRNA flu vaccine after initial ...

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 FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

The flu vaccine is its first using mRNA technology for influenza.

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 ...

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.

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...

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.

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