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

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

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

Moderna (MRNA) is back in focus after completing a clinical study of multiple mRNA vaccines targeting several respiratory ...

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

The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.

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

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

WASHINGTON (AP) — The U.S. 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 ...