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Treatment of adults with locally advanced, unresectable (stage III) non- small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2] Repotrectinib
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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.
Approved in March 2019 for CIS, RRMS and SPMS [11] [12] Ozanimod: oral. It was approved by the FDA in March 2020 with the trade name Zeposia [13] [14] [15] Ponesimod (Ponvory) Five monoclonal antibodies: Alemtuzumab (Lemtrada, Campath). [16] Natalizumab (Tysabri) Ocrelizumab (Ocrevus) [17] which is also approved for primary progressive (PPMS)
In 2020, the FDA received 34 requests for RMAT status, of which 12 (35.3%) were granted. RMAT designated drugs include the novel CAR-T therapy Kymriah and betibeglogene autotemcel for beta thalassemia. [34] As of 31 March 2021, 62 requests for RMAT status have been granted. [35]
Studies also show that the drug, scoring an 11 out of 12 as a gerotherapeutic, targets hallmarks of aging like cellular senescence by protecting DNA, decreasing inflammation, and improving insulin ...
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.
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 condition. [2] Drug companies seeking to sell a drug in the United States must first test it.