Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010 CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an ...

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.

The FDA rarely refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions. Moderna has requested an urgent ...

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing because “the company refused to follow very clear FDA guidance from 2024 to test ...

Moderna's mRNA-1010 flu vaccine for older adults could be made available by the end of 2026, the pharmaceutical company announced on Friday.

CHMP adopts positive opinion on Moderna’s mRNA combination vaccine ‘mCOMBRIAX’ against influenza, Covid-19: Cambridge, Massachusetts Wednesday, March 4, 2026, 16:00 Hrs [IST ...

Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its investigational seasonal influenza vaccine, mRNA-1010, following a Type A ...

The Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier ...