#FDA approval

People ages 6 months and older are eligible for new Moderna and Pfizer-BioNTech boosters targeting XBB.1.5 omicron variant.

Arexvy RSV vaccine is now approved for individuals age 60 and older.

An FDA advisory committee expressed concerns about the safety of the fatty liver disease treatment.

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.

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

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

The PreHevbrio vaccine produces higher antibody levels and offers faster protection.

Molnupiravir is authorized for people at high risk for severe COVID-19 when other treatment options are not available.

Paxlovid, which reduces the risk of hospitalization or death by about 90%, is expected to be a game-changer.

Molnupiravir, the first oral antiviral for COVID-19, reduces the risk of hospitalization or death if started within five days.

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

Vaccine effectiveness for children ages 5 to 11 was 91%, and serious side effects are rare.

An advisory panel reviewed follow-up data on checkpoint inhibitors, voting to maintain four approvals and rescind two.

Full approval could encourage more people to get vaccinated and raises the prospect of off-label use.

The booster is recommended for organ transplant recipients, people receiving cancer treatment and people with advanced or untreated HIV.