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

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

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 ...

The emergency use authorization continues until the health secretary ends it. Existing product authorizations can continue, and new ones, such as the updated COVID-19 vaccines, can be issued as ...

Pemgarda, made by Invivyd, is an infusion drug approved for use by patients who are immunocompromised to help protect against COVID-19 infection.

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 ...

It is a protein-based vaccine, and such vaccines use harmless protein fragments of the virus to teach the immune system how to spot the virus and fight it off.

Moderna says it plans to seek emergency use authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine in children under age 6.

Novavax asked the Food and Drug Administration on Monday to grant an emergency use authorization for its protein-based COVID-19 vaccine.

A Food and Drug Administration advisory panel on Tuesday voted to endorse emergency use authorization for Merck's experimental COVID-19 pill.