#Food and Drug Administration

People 65 and older and immunocompromised people can get a second bivalent booster; most unvaccinated people now need only one initial shot.

Monoclonal antibodies used to prevent COVID-19 in immunocompromised people aren’t active against new virus variants.

Older people, immunocompromised people and those with underlying health conditions can benefit most from additional shots.

Updated Pfizer-BioNTech and Moderna bivalent boosters contain spike proteins from the original and BA.4 and BA.5 omicron variants.

Updated boosters could go to the “worried well” who have good insurance rather than to those at highest risk.

The engineered protein vaccine was highly effective in a clinical trial but faced a long delay for authorization.

FDA advises people to perform repeat testing following a negative at-home COVID-19 test, to reduce the risk an infection may be missed.

An unusual alliance among senators emerged in the push to allow for the importation of drugs from Canada and the United Kingdom.

After a long wait, the FDA authorizes Pfizer and Moderna vaccines for children as young as 6 months old.

A study found that only 43% of clinical trials reported race and ethnicity. The FDA issued guidance to address these inequalities.

The diagnostic test can provide results in less than three minutes.

Immunocompromised people ages 12 and older are also eligible for an additional shot.

Testing advances made during the COVID-19 pandemic may lead to “test and treat” approaches for hepatitis C. But there’s a holdup.

Some think the U.S. should have had an equivalent of Operation Warp Speed for COVID-19 testing.

Robert Califf headed the Food and Drug Administration for 10 months under Obama. Will he manage to implement his ideas this time around?

Many people who received any of the authorized COVID-19 vaccines are now eligible for an additional dose of their choice.