The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

The FDA agreed to review Moderna’s seasonal flu shot after the vaccine maker said it would run extra tests in the elderly.

Feb 19 (Reuters) - German biopharmaceutical company BioNTech sued Moderna in Delaware federal court on Thursday, alleging ...

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.

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

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

Moderna held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

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

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

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

The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday. Last week, the FDA sent a missive to Moderna ...