#Food and Drug Administration

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

FDA issued draft guidelines on a new blood donation policy; it now seeks public comment before the changes are finalized.

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.

Having eased its ban on blood donations from gay and bi men in 2020, the FDA may soon use a questionnaire to assess individual risk.

Except for HIV tests, the FDA has not approved sexually transmitted infection test kits for use outside medical settings.

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

Cities are getting fewer doses than expected due federal government’s new split-dose strategy.

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

The FDA has authorized a new administration method that splits a single Jynneos vial to vaccinate five people.

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.

The American Medical Association supports a ban on menthol cigarettes, which could save up to 654,000 lives worldwide over 40 years.

The potentially lifesaving prescription drug buprenorphine is less available to women and Black and Latino people with opioid addiction.

The FDA is investigating the source of an outbreak that has led to 12 hospitalizations.

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