The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

WASHINGTON -- Moderna is applying for full government approval for its COVID-19 vaccine. The company said it is submitting trial data to the Food and Drug Administration on a rolling basis over the ...

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the ...

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License ...

Stream Connecticut News for free, 24/7, wherever you are. The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for ...

Moderna says the Food and Drug Administration has issued full approval for its COVID-19 vaccine for use in people aged 18 and older. The company made the announcement in a press release on Monday ...

Dr. Anthony Fauci on Tuesday said that there's a chance that Moderna's COVID-19 booster shot may not have FDA and CDC approval by the White House's Sept. 20 target date, though he expects that ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from respiratory ...