Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

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

MRNA Down Nearly 10% as FDA Refuses to Review Influenza Vaccine BLA

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...
Investor's Business Daily on MSN

Moderna plunges after FDA rejects its messenger-RNA-based flu shot

The FDA rejected Moderna's experimental flu vaccine Tuesday in a move that proved to be a blow to recently hot Moderna stock.
Dealbreaker on MSN

Moderna says FDA refusal to review mRNA flu vaccine contradicts federal rules, prior guidance

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine.
AOL

Flu season is here. How much is the vaccine without insurance?

Flu season, when influenza and other common respiratory illnesses spread further, has arrived – which means if you haven't received one already, it may be time for your flu vaccine. While vaccine ...
PharmExec

FDA Sends Refusal-to-File Letter to Moderna for Seasonal Influenza Vaccine, Enters Long-Term Agreement with Government of Mexico

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...
Arkansas Democrat-Gazette

Walk-In flu vaccine services available for veterans in Northwest Arkansas, River Valley

Veterans in Northwest Arkansas and the River Valley have several walk-in flu vaccination options through the Veterans Health Care System of the Ozarks this flu season. The system announced in a news ...