The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

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

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

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, ...

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

Moderna MRNA announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 ...

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

RFK Jr. cancels U.S. Preventive Services Task Force meeting; the Department of Health and Human Services backtracked on its claim that it would release ethics forms for new members of the Advisory ...

US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert ...

SILVER SPRING, MD — The FDA gives full approval for Moderna’s COVID-19 vaccine in children aged 6 months through 11 years who ...