#FDA approval

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

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.

Gilead Sciences’ direct-acting antiviral regimen was previously approved for adults.

Acting Commissioner Ned Sharpless will return to lead the National Cancer Institute.

The indication for AbbVie’s regimen includes those with compensated cirrhosis.

September 4, 2019, the U.S. FDA released their recent approval of new dosage forms of Sovaldi and Harvoni for children 3 to 12 years of age.

A placebo-controlled study of obeticholic acid showed it improved liver fibrosis with no worsening of non-alcoholic steatohepatitis.