Idarucizumab receives full FDA approval

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Dabigatran (Pradaxa)
Photo courtesy of
Boehringer Ingelheim
The US Food and Drug Administration (FDA) has granted full approval to idarucizumab (Praxbind®), the specific reversal agent for dabigatran etexilate mesylate (Pradaxa®). Idarucizumab received accelerated approval from the FDA in October 2015. Now, the drug has full approval for use in reversing dabigatran’s anticoagulant effects in... [Read Article]
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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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Injectable hydrogels stop bleeding, promote healing

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Hydrogels
Photo by Kathy Atkinson,
University of Delaware
Biomedical engineers have developed hydrogels that can act as an “injectable bandage,” according to preclinical research published in Acta Biomaterialia. The team engineered injectable hydrogels that were able to promote hemostasis and facilitate wound healing in vitro. “Injectable hydrogels are promising materials for achieving hemostasis in... [Read Article]
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Test for HIT receives CE mark

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Platelet-rich plasma
HIT Confirm, a test used to diagnose heparin-induced thrombocytopenia (HIT), has received the CE mark. This means the test meets regulatory requirements and health, safety, and environmental protection standards for products sold within the European Economic Area. HIT Confirm is a flow cytometry-based test developed by Emosis. The test can be... [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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CHMP recommends approval for generic prasugrel

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Prescription drugs
Photo courtesy of the CDC
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to a generic version of prasugrel called Prasugrel Mylan. Mylan S.A.S. is seeking approval for this product to be co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in... [Read Article]
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