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 ...

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.

Moderna's mRNA-1010 flu vaccine for older adults could be made available by the end of 2026, the pharmaceutical 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.

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...

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 Food and Drug Administration reversed course on Wednesday and agreed to formally review Moderna’s new flu vaccine that uses mRNA technology, the company announced in a news release. Earlier this ...

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