Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and ...

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

Moderna is seeking emergency use authorization from the FDA for its Covid-19 vaccine for children 6 months through 5 years of age.

While an emergency use authorization may be the speediest way for public health officials to begin a vaccination campaign, it may not end up shaving that much time off of a more traditional route to ...

What is an emergency use authorization? An emergency use authorization is a tool that the FDA uses to strengthen the nation’s response to public health emergencies such as COVID-19.

The FDA issued an emergency use authorization to drug-maker Lilly for bamlanivimab, a monoclonal antibody that mimics the immune system’s response to infection with the virus that causes COVID-19.

Emergency use authorization can be granted when a vaccine meets certain standards during a time when there is extreme risk to public health.

Until recently, you may have never heard the term “Emergency Use Authorization.” These words entered the lexicon as people around the world anxiously read updates about the COVID-19 pandemic ...

To win emergency use authorization, or EUA, drug or device makers may present the FDA with less evidence of a product’s safety and effectiveness than is required for full approval.

Emergency use authorization can be granted when a vaccine meets certain standards during a time when there is extreme risk to public health.