Fostamatinib approved to treat adults with chronic ITP

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Fostamatinib (Tavalisse)
Photo courtesy of
Rigel Pharmaceuticals
The US Food and Drug Administration (FDA) has granted approval for the oral SYK inhibitor fostamatinib disodium hexahydrate (Tavalisse™). Fostamatinib is now approved for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Rigel... [Read Article]
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FDA expands approved use of product for VWD

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Recombinant von Willebrand
factor (Vonvendi)
Photo courtesy of Shire
The US Food and Drug Administration (FDA) has expanded the approved use of Vonvendi, a recombinant von Willebrand factor product. Vonvendi is now approved for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD). Vonvendi was previously FDA-approved... [Read Article]
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Emicizumab receives breakthrough designation

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Emicizumab (Hemlibra)
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to emicizumab (Hemlibra®) for patients who have hemophilia A without factor VIII inhibitors. Emicizumab is a bispecific factor IXa- and factor X-directed antibody approved by the FDA for routine prophylaxis to prevent or reduce the... [Read Article]
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Deaths in patients on emicizumab

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Emicizumab (Hemlibra)
Photo from Business Wire
Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra). All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician. The National Hemophilia Foundation and Hemophilia Federation of America reported... [Read Article]
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PK dosing software available in US

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Doctor with tablet
Photo by George Hodan
Pharmacokinetic (PK) dosing software intended for use in patients with hemophilia A is now available in the US. This free, web-based, prescription software—myPKFiT for ADVATE—is intended to aid healthcare professionals in personalizing the dose and schedule of ADVATE, a full-length recombinant factor VIII product. The software... [Read Article]
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