#FDA approval

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.

Alzheimer’s advocates laud the approval of Aduhelm, but experts raise questions about its effectiveness and cost.

The Epclusa and Mavyret combination pills are now indicated for kids as young as age 3.

The Pfizer-BioNTech vaccine was 100% effective in a study of adolescents; trials for younger children are now underway.