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 ...

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

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

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 ...

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

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

Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD ...

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

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 Moderna vaccine must be kept refrigerated between 36 and 46 degrees Fahrenheit. Leaving it out of its temperature range can compromise its potency and "denature" the doses, according to Moderna.