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 ...

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

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

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

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.

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

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

US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert F. Kennedy Jr.’s controversial policy that restricts access to the shots ...

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

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...