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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The US Food and Drug Administration (FDA) approval of marstacimab is based on the BASIS study (NCT03938792), [1] an open-label, multi-center study in 116 adult and pediatric male participants with either severe hemophilia A or severe hemophilia B, both without inhibitors. [4]
Delandistrogene moxeparvovec (Elevidys): treatment for Duchenne muscular dystrophy [7] [8] Elivaldogene autotemcel (Skysona): treatment for cerebral adrenoleukodystrophy [9] Etranacogene dezaparvovec (Hemgenix): AAV-based treatment for hemophilia B [10] Exagamglogene autotemcel (Casgevy): treatment for sickle cell disease. [11]
Hympavzi is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...
U.S. officials on Thursday approved drugmaker BioMarin's gene therapy for the most common form of hemophilia, a $2.9 million infused treatment that can significantly reduce dangerous bleeding ...
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