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

Even so, the panel agreed with the doctors that the line between government speech and private expression can get blurry.

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

Moderna (MRNA) stock in focus as the company cancels plans for an mRNA manufacturing plant in Japan amid a challenging ...

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

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

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

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

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

The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.