THE VACCINE MAKER MODERNA decided this past week to tell the world about bad news it had received from the federal government ...

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...

"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

Correction: This story was updated to clarify a statement given by Department of Health and Human Services spokesperson Andrew Nixon. Moderna said on Tuesday that the Food and Drug Administration (FDA ...

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

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

Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...

The federal government on Wednesday told its side of the story amid a disagreement with Moderna after the FDA decided to ...

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.