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

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

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.

Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use ...

Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 ...

The Food and Drug Administration has set March 8 as the end of its emergency use authorization (EUA) for Paxlovid for adult patients, the agency has said this week. The medication is given to those ...

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for ...

With Tuesday's emergency use authorization, federal health officials say 400,000 doses of vaccine will be turned into 2 million shots. This should significantly allow more people to get vaccinated.

The Food and Drug Administration denied an emergency use authorization for fluvoxamine as a SARS-CoV-2 antiviral.

Novavax has formally submitted a request for the U.S. Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States.