The US Food and Drug Administration (FDA) has approved US mRNA specialist Moderna supplemental Biologics License Application ...

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

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

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

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

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

The Food and Drug Administration Thursday granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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

FDA grants full approval to Moderna's COVID-19 vaccine for children aged 6 months to 11 years with medical vulnerabilities, ...

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 ...