The recommendation from regulators paves the way for the shot’s approval in the European Union at a time the company is ...

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

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

By Bhanvi Satija Feb 27 (Reuters) - Europe's medicines regulator recommended approval for Moderna's COVID and flu combination vaccine on Friday, putting it on track to become the first single shot to ...

COMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending ...

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

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for ...

Signed Memorandum of Understanding supports "Plan Mexico," Mexico's strategic initiative to build a local mRNA ...

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

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

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