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

Vaccine maker Moderna says the Food and Drug Administration will decide whether to approve its new flu shot for older adults ...

In a sudden reversal, the US Food and Drug Administration has agreed to review Moderna’s experimental mRNA influenza vaccine.

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

Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

President Trump called Commissioner Marty Makary to the White House to discuss his frustration with the agency handling of ...

The FDA’s decision not to review the flu shot, which uses messenger RNA and is known as mRNA-1010, was unusual and drew ...

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

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults.