Mavyret approved as 8-week treatment for hep C, compensated cirrhosis

(HealthDay)—Approval of Mavyret (glecaprevir and pibrentasvir) tablets has been expanded to eight-week treatment for treatment-naive patients aged 12 years and older with chronic hepatitis C virus (HCV) genotypes 1 through 6 and compensated cirrhosis, the U.S. Food and Drug Administration announced last week. Mavyret is the first eight-week treatment approved for any treatment-naive HCV patients, regardless of cirrhosis status or […]

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First anticoagulant approved for preventing VTE recurrence in children

(HealthDay)—Fragmin (dalteparin sodium) injection has been granted the first approval for subcutaneous use in preventing recurrence of symptomatic venous thromboembolism (VTE) in children aged 1 month or older, the U.S. Food and Drug Administration announced. Fragmin has been approved for use in adults since 1994. Approval in children was based on a trial of 38 pediatric patients with symptomatic deep […]

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Benlysta approved for children with lupus

(HealthDay)—The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body. Approved for adults since 2011, Benlysta is the first lupus treatment in the United States approved for children, the agency said in a news release. “While […]

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