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Three phase III clinical trials have evaluated crovalimab in both people who were C5 inhibitor–naive and those switching to crovalimab from other C5 inhibitors. [10] COMMODORE 1 [11] is a phase III randomized clinical trial comparing crovalimab vs eculizumab in people with paroxysmal nocturnal hemoglobinuria treated with C5 inhibitors. [12]
To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]
Phase III trials continue to monitor toxicity, immunogenicity, and SAEs on a much larger scale. [6] The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval and then general production. In the United States, the Food and Drug Administration (FDA) is responsible for approving vaccines. [7]
Satralizumab was approved for medical use in the United States in August 2020. [20] [14] [11] The FDA granted the application for satralizumab fast track and orphan drug designations. [6] The FDA granted the approval of Enspryng to Genentech Inc. [6] Satralizumab is the third approved treatment for NMOSD in the United States. [6]
Based on additional studies, the FDA granted full approval in 2016 and updated the label to include people with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor therapy is indicated.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
In March 2024, the FDA approved amivantamab, in combination with carboplatin and pemetrexed, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. [11] The FDA also granted traditional approval to ...