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FDA to review Moderna's mRNA flu vaccine after initial rejection

Moderna announced the Food and Drug Administration (FDA) will review its new mRNA flu vaccine, changing course less than two weeks after the agency said it refused to accept Moderna's application. In ...
WPBF

FDA reverses course and will review Moderna’s mRNA flu shot, company says

The U.S. Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday.About two weeks ago, the FDA sent Moderna a ...
Detroit Free Press

FDA reverses course, agrees to review Moderna's flu vaccine

The Food and Drug Administration reversed an earlier decision to not review Moderna's flu vaccine and will evaluate the company's modified application for a potential approval, Moderna said on Feb. 18 ...
New York Post

FDA reverses decision not to review Moderna’s new flu vaccine

The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday. Last week, the FDA sent a missive to Moderna ...

Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026

CAMBRIDGE, MA / ACCESS Newswire / April 6, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will ...
phillyvoice.com

FDA's abrupt flip‑flop on Moderna's mRNA flu shot highlights growing risks to drugmakers of investing in vaccines

The Food and Drug Administration's decision, made public on Feb. 10, to not review an application to approve Moderna's proposed mRNA-based flu vaccine set off a firestorm of criticism from public ...
The Hill

FDA reverses course, will review Moderna’s mRNA flu vaccine candidate

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.