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The first FDA-approved therapeutic monoclonal antibody was a murine IgG2a CD3 specific transplant rejection drug, OKT3 (also called muromonab), in 1986. This drug found use in solid organ transplant recipients who became steroid resistant. [39] Hundreds of therapies are undergoing clinical trials. Most are concerned with immunological and ...
See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page. This is a dynamic list and may never be able to satisfy particular standards for completeness. You can help by adding missing items with reliable sources .
Muromonab-CD3 was approved by the U.S. Food and Drug Administration (FDA) in 1986, [5] making it the first monoclonal antibody to be approved anywhere as a drug for humans. In the European Communities , it is the first drug to be approved under the directive 87/22/EWG, a precursor of the European Medicines Agency (EMA) centralised approval ...
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Aducanumab, sold under the brand name Aduhelm, is a monoclonal antibody designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. [10] It was developed by Biogen and Eisai. [11] Aducanumab is given via intravenous infusion. [5] Aducanumab was ...
Broken down into ab-ci-xi-mab, its name shows the drug to be a chimeric monoclonal antibody used on the cardiovascular system. This and the following two names would look the same if the 2009 convention were applied. [37] The name of the breast cancer medication trastuzumab can be analyzed as tras-tu-zu-mab. Therefore, the drug is a humanized ...
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1] [2] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.
The first commercial product from the GlycArt acquisition was obinutuzumab, which as Gazyva gained FDA approval in November 2013 for the treatment of chronic lymphocytic leukemia. [ 3 ] [ 4 ] [ 5 ] Kyowa Hakko Kirin's "Potelligent" platform uses a CHO cell line in which FUT8 has been knocked out, and which produces antibodies with little to no ...