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(HealthDay)—Taking the hepatitis C drugs Mavyret, Zepatier or Vosevi can trigger rare cases of severe liver problems or liver failure in patients who already have moderate-to-severe liver impairment, the U.S. Food and Drug Administration warned Wednesday. The agency has identified 63 cases of worsening liver function, some resulting in liver failure or death, among patients taking the drugs. While the […]
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(HealthDay)—Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules have been approved to treat adults with cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM), the U.S. Food and Drug Administration announced today. Recommended dosage is four 20-mg capsules of Vyndaqel once daily or a single 61-mg capsule of Vyndamax once daily, according to the manufacturer. The two drugs, which are the first approved […]
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(HealthDay)—Two drugs have been approved by the U.S. Food and Drug Administration for the treatment of rare blood diseases, the agency announced Friday. Elzonris (tagraxofusp-erzs) infusion was granted the first approval for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children aged 2 years and older. Researchers investigated the efficacy of Elzonris in two patient cohorts […]
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The U.S. Food and Drug Administration (FDA) has expanded approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. Today’s approval includes treatment of diffuse large B-cell lymphoma (DLBCL) – the most […]
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