FDA Grants Breakthrough Therapy Designation to Tecentriq, Avastin Combo for Liver Cancer
July 20th 2018Genentech announced that the FDA has granted Breakthrough Therapy Designation to atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for patients with the most common form of liver cancer.
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First Darunavir-Based Single-Tablet Treatment Regimen for HIV Wins FDA Approval
July 19th 2018Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg) is the first and only complete darunavir-based single tablet regimen (STR) for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults.
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First Darunavir-Based Single-Tablet Treatment Regimen for HIV Gets Approval
July 18th 2018The approval is based on data from 2, phase 3 studies, AMBER and EMERALD, which evaluated the safety and efficacy of Symtuza compared with a control regimen in adults with no prior antiretroviral (ARV) history and in virologically suppressed adults.
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Investigational Antiviral Flu Drug Achieves Efficacy Goal in Phase 3 Trial
July 18th 2018The phase 3 CAPSTONE-2 study of the safety and efficacy of baloxavir marboxil in patients at high risk of complications due to influenza (flu) has met the primary objective of efficacy of a single dose of baloxavir marboxil compared to placebo.
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