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Covid, Moderna and FDA

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.

Infectious Disease Advisor · 2h

FDA Fully Approves Moderna’s COVID-19 Vaccine for Some Young Kids

Moderna’s COVID-19 vaccine has received full FDA approval for use in children at higher risk for severe illness.

USA TODAY · 3d

Moderna COVID vaccine gets FDA green light for kids 6 months to 11 years

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday.

16m

FDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger Adults

Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59.

16hon MSN

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.

Pharmaceutical Technology7h

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

STAT4d

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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