The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

Capricor is now looking forward to a key panel review of its application seeking approval for Deramiocel. ・Replimune faces back-to-back high-stakes FDA events next week for its lead drug RP1. ・Just ...

Add Yahoo as a preferred source to see more of our stories on Google. Moderna said the FDA's refusal was inconsistent with previous feedback from the agency. - Graham Hughes/Bloomberg/Getty Images The ...

Moderna remains a Sell as regulatory setbacks, notably the FDA's Refusal-to-File for mRNA-1010, highlight persistent execution and approval risks. The RTF for mRNA-1010 delays potential influenza ...

Moderna's flu vaccine may not fuel a further recovery for the hard-hit COVID-19-affected stock.

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. The news is the ...

Investors should note that in February, the FDA issued a refusal-to-file letter regarding Moderna’s influenza vaccine, citing the choice of a standard-dose seasonal influenza vaccine as the sole ...

A Food and Drug Administration advisory panel on Thursday recommended the approval of Moderna’s mRNA-based flu shot for older adults.

The U.S. Food and Drug Administration (FDA) refused to consider Moderna’s application for a new flu vaccine using mRNA technology, the company announced Tuesday, a decision that could delay the ...

Add Yahoo as a preferred source to see more of our stories on Google. In December 2025, Moderna submitted an application to the FDA to approve the first mRNA-based flu vaccine. Catherine Falls ...

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...