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The FDA’s revision was based on two randomized trials of Viread (tenofovir disoproxil fumarate) use in 2- through 11-year-olds.
Gilead Sciences has released multiple combo tablets that contain the updated tenofovir, which is linked to improved bone and kidney makers.
Congress passes legislation to increase access to unapproved therapies for life-threatening diseases.
Experts warn that the plant, which is used to treat pain and symptoms of withdrawal from heroin, can be dangerous — and even deadly.
He’ll oversee the FDA, Medicare and Medicaid at a time when soaring drug prices remain a contentious political topic.
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
Puerto Rico’s main exports are medical devices and pharmaceuticals, including HIV and cancer drugs.
A formal petition filed with federal drug regulators last week seeks to prevent thousands of accidental overdose deaths every year.
The Food and Drug Administration has approved AbbVie’s once-daily Mavyret to treat all six major genotypes of hepatitis C virus (HCV).
The FDA has expanded approval of the direct-acting antiviral treatments Sovaldi and Harvoni for adolescents ages 12 and older.
It approved 12 weeks of Gilead Sciences’ Vosevi for the re-treatment of adults with all genotypes of HCV who do not have cirrhorsis.
The two-drug regimen can cure the virus in as little as eight weeks.
The agency has asked Endo Pharmaceuticals to stop selling Opana ER, a painkiller that’s been linked with outbreaks of HIV and hepatitis C.
The number of veterans treated for HCV by the Veterans Health Administration (VA) surged along with cure rates.
Using supplements can be risky for people with liver disease.
All the participants were cured of hep C. Although some saw their hep B viral load rise, other measures of the disease looked good.
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