The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Key Points Moderna has struggled since COVID-19 vaccine demand has shrunk.The stock has correspondingly declined, as revenue has nosedived over the last few years.The long game is clinical trials in ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

Compared to the standard shot, the mRNA vaccine had an overall vaccine efficacy that was 26.6 percent higher, and 27.4 percent higher in participants who were aged 65 years or older. Previous trial ...

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

Pfizer and its German partner BioNTech asked London's Court of Appeal on Thursday to overturn a ruling that their COVID-19 vaccine infringed one of Moderna's patents, in the latest round of a ...

The long and winding journey of Moderna’s mRNA flu vaccine toward regulators has come one step closer with a phase 3 win over an approved competitor.

SILVER SPRING, MD — The FDA gives full approval for Moderna’s COVID-19 vaccine in children aged 6 months through 11 years who are at an increased risk of the disease. The shot was previously available ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...