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Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
In August 2024, the US Food and Drug Administration granted accelerated approval to Adaptimmune's Tecelra, a therapy against a rare form of cancer. Tecelra is the first T cell therapy to be approved for use against a solid tumor.
Because ADA is essential for maintaining healthy lymphocytes (white blood cells that fight off infections), the immune system of people with ADA-SCID does not work properly and without effective treatment they rarely survive more than two years. [1] Strimvelis is the first ex vivo autologous gene therapy approved by the European Medicines ...
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical ...
This week, the Food and Drug Administration (FDA) announced that food companies in the U.S. have until January 15, 2027 to rid their products of Red Dye No. 3. (Drug manufacturers, meanwhile, have ...
The FDA used a small study from Europe and results from 135 dogs injected in the U.S. That is correct! This drug was approved for sale after only 135 dogs received the injection (2).
Substrate reduction therapy is FDA approved and there is at least one treatment available on the market. [10] Gene therapy aims to replace a missing protein in the body through the use of vectors, usually viral vectors. [11] In gene therapy, a gene encoding for a certain protein is inserted into a vector. [11]