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

An expert panel of the EU drug regulator, the European Medicines Agency (EMA) on Friday recommended marketing authorizations ...

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

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

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

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

Moderna (MRNA) stock rises as the company's Spikevax COVID-19 vaccine gets FDA approval for kids 6 months-11 years at higher risk. Read more here.

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months through 11 years. Novavax's COVID shot (Nuvaxovid) is fully approved for people ...

The FDA has given full approval to Moderna's COVID-19 shot, Spikevax, allowing it to be used in children 6 months to 11 years old, with some limits on who can get it.