The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...

The company has also filed for FDA approval of its flu+Covid combination vaccine, mRNA-1083. If approved, it will be the first in the US to offer protection against flu and Covid-19 in a single shot.

A new kind of vaccine is changing how people think about preventing breast cancer. Not just any breast cancer—this one ...

Marks said the delay to an approval decision on Novavax's COVID-19 vaccine, which was expected to be greenlighted earlier this month by the FDA, was concerning. And he warned that his own ouster ...

Shares of vaccine makers fell after US Health and Human Services Secretary Robert F. Kennedy Jr. raised doubts about the ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological ...

Marks served as head of the FDA's Center for Biologics Evaluation and Research, which oversees the approvals of vaccines as well as other kinds of medical products that are derived from living ...

The move to keep FDA staff working to furnish government records related to its approval of covid vaccines came amid a purge of FOIA workers across federal health agencies, including the FDA ...

The federal government doesn’t mandate childhood vaccines; rather, all 50 states require them for children attending public school. The FDA approves vaccines based on safety and efficacy ...