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The FDA approved only the five-mg, twice-daily dose on the grounds that a higher dose was not considered to have an adequate risk-to-benefit ratio. [34] In September 2020, the FDA approved tofacitinib for the treatment of children and adolescents two years of age and older with active polyarticular course juvenile idiopathic arthritis. [35]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Zenocutuzumab was approved for medical use in the United States in December 2024. [3] [4] [5] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin 1 gene fusion. [3] The FDA considers it to be a first-in-class ...
Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease, [4] [5] rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Just because the FDA approves a drug doesn’t necessarily mean that Medicare will pay for it for all patients. Before Leqembi was approved, another similar medication was approved called Aduhelm.
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
About Compounded Tirzepatide. Compounded tirzepatide is a formulation of tirzepatide — a medication for type 2 diabetes and weight loss. Tirzepatide is the active ingredient in the FDA-approved ...