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News

Moderna, FDA and COVID

U.S. News & World Report · 1d
FDA Fully Approves Moderna's COVID Vaccine for Some Young Kids
The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather than used under emergency authorization, STAT News reported. The vaccine can now be given to children ages 6 months through 11 years, but only if they have at least one health issue that increases their COVID risk.
STAT · 1d
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.
BioSpace · 1d
Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids
The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.
WOODTV.com on MSN5h
Moderna gets full FDA approval for kids COVID-19 vaccine
The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.
STAT
2d
Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

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