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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
In August 2019, it was approved by U.S. FDA for treatment of giant-cell tumor of the tendon sheath (GC-TS). [2] [6] [7] Pexidartinib is available in the US only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program. [2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
The FDA granted the approval of Inmazeb to Regeneron Pharmaceuticals with an indication for the treatment of infection caused by Zaire ebolavirus in October 2020. [ 2 ] [ 6 ] The drug has also received orphan drug designation from the European Medicines Agency .
Deep brain stimulation was approved by the U.S. Food and Drug Administration in 1997 for essential tremor, in 2002 for Parkinson's disease, and received a humanitarian device exemption from the FDA in 2003 for motor symptoms of dystonia. [23] It was approved in 2010 in Europe for the treatment of certain types of severe epilepsy. [24]
In May, the Food and Drug Administration approved as many as 13 new drugs, higher than the eight approved in the same month last year. 3 Stocks to Buy on New Drug Approvals by FDA Skip to main content
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Selumetinib was approved for medical use in the United States in April 2020, [15] and in the European Union in June 2021. [9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication .