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In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non- small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]
inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
This is a complete list of androgens/anabolic steroids (AAS) and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. AAS like testosterone are used in androgen replacement therapy (ART), a form of hormone replacement therapy (HRT), and for other indications.
Lecanemab (a.k.a. leqembi) has received full approval from the U.S. Food and Drug Administration. This is the first FDA-approved treatment to help slow the progression of Alzheimer’s disease.
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]
Bempedoic acid was approved for use in the European Union in April 2020, [3] and the combination bempedoic acid/ezetimibe was approved in March 2020. [ 15 ] [ 16 ] In February 2020, bempedoic acid was approved for use in the United States both as a standalone drug (brand name Nexletol) [ 5 ] [ 17 ] [ 18 ] [ 19 ] and in a fixed-dose combination ...