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Congress passes legislation to increase access to unapproved therapies for life-threatening diseases.
Neither does the focus on Pharmacy Benefits Managers.
The integrase inhibitor is included in the single-tablet HIV regimens Triumeq and Juluca.
The approval is based on a small study of 15- to 17-year-olds.
The newly approved single-tablet regimen contains the integrase inhibitor bictegravir plus emtricitabine and tenofovir alafenamide.
The Food and Drug Administration approves antibody treatment Trogarzo for multidrug-resistant HIV.
This long-acting drug is linked to undetectable viral loads in former prisoners with substance use disorders.
The FDA commissioner wants drugmakers to “end the shenanigans.”
Juluca is a single-tablet regimen for HIV.
Researchers will genetically engineer participants’ CD4 cells, disabling the attachment of the virus.
He’ll oversee the FDA, Medicare and Medicaid at a time when soaring drug prices remain a contentious political topic.
Puerto Rico’s main exports are medical devices and pharmaceuticals, including HIV and cancer drugs.
ViiV Healthcare has applied to the FDA for approval of the first two-drug antiretroviral (ARV) regimen to treat HIV.
The single-tablet HIV treatment regimen includes the experimental integrase inhibitor bictegravir and the contents of Descovy.
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.
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