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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.
The Johnson & Johnson vaccine, which is easier to store and deliver, will help speed up the coronavirus vaccine rollout.
Moderna’s coronavirus vaccine is 94% effective in preventing symptomatic COVID-19—and it may also reduce asymptomatic infection.
The test is authorized for individuals two years of age or older, including those not showing symptoms.
Pfizer/BioNTech’s coronavirus vaccine is 95% effective for preventing symptomatic illness.
The antiviral drug is the first treatment for the new coronavirus to be approved in United States.
“The SalivaDirect test...is yet another testing innovation game changer that will reduce the demand for scarce testing resources.”
The regulatory agency requested further data to show whether its benefits outweigh its risks.
The immunotherapy and targeted therapy combo improved both overall survival and patient-reported outcomes.
Tests like the one approved this week can show who is likely to be immune, but it’s not yet clear how long such immunity lasts.
A third of patients treated with Opdivo plus Yervoy experienced complete or partial tumor remission.
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