#Food and Drug Administration

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

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

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.

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

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.

Third dose OK’d for people over 65, those at risk for severe COVID-19 and those at high risk of exposure to the coronavirus.

The committee voted against third shot for all adults, however, casting doubts on Biden’s booster plan.