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

Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics ...

Moderna (MRNA) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted an opinion recommending marketing authorization for an updated formulation of ...

Moderna (MRNA) nnounced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for an updated ...

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

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season. About Moderna ...

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

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.

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

Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political ...