COVID-19

The US Food and Drug Administration has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents aged 12 through 15 years.

On February 27, 2021, the US Food and Drug Administration issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine. This is the third vaccine authorized by the FDA to prevent COVID-19. ...

The US Food and Drug Administration has issued an emergency use authorization for a new combination of monoclonal antibodies for treating patients with mild to moderate COVID-19 who are at risk of...

The FDA released a letter to clinical providers warning that several molecular tests for COVID-19 may result in false negatives and offers recommendations.

In an emergency use authorization, the FDA has approved a new COVID-19 home test for use with a prescription.

The US Food and Drug Administration has issued an emergency use authorization for a rapid, lateral flow antigen test that is the first over-the-counter at-home diagnostic test for COVID-19.

The first at-home COVID-19 collection kit has been approved for adults aged 18 years or older. Find out more about the kit here.

The US Food and Drug Administration advisory committee has voted 17 to 4 in favor of recommending the authorization the Pfizer/BioNTech COVID-19 mRNA vaccine (BNT162b2).

The panel released criteria for the emergency use of bamlanivimab in certain populations but has not indicated FDA approval of the treatment.

The FDA has approved the first option for the treatment of adult and pediatric patients aged 12 years or older with COVID-19 who require hospitalization.