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

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

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 U.S. Food and Drug Administration (FDA) recently informed Moderna that it would not review the company’s application for approval of its new flu vaccine, which is its first using mRNA technology ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

European regulators have approved Moderna Inc.’s novel combination flu and Covid shot, handing a victory to the embattled ...

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 Food and Drug Administration’s refusal to even file Moderna’s application for its first mRNA-based flu shot is more than a bureaucratic hiccup. It is a rare public rebuke of a company that helped ...

The Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The news is the ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.