Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

What Happened? Shares of biotechnology company Moderna (NASDAQ:MRNA) fell 3.6% in the morning session after JPMorgan added ...

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

Explore last week's key healthcare market trends, top gainers & losers, major deals, Trump's tariff plans, FDA approvals, and significant legal updates.

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one ...

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 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.

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 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 ...