Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

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

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

Moderna’s stock was surging after the FDA said it would review the biotech’s flu-vaccine candidate, a week after it had refused to do so.

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.

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

The anti-science, anti-medicine mindset of Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines.

CAMBRIDGE, MA / ACCESS Newswire / October 22, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced topline results from a Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, the Company’s ...

Moderna said Wednesday that its experimental mRNA-based seasonal flu vaccine generated a stronger immune response against four strains of the flu virus than a currently marketed vaccine in a Phase 3 ...

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...