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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
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]
Breakthrough grossed $40.7 million in the United States and Canada, and $9.7 million in other territories (including $5.9 million in Brazil), [19] for a worldwide total of $50.4 million. [ 2 ] [ 20 ] In the United States and Canada, the film was released alongside Penguins , and was projected to gross $13–17 million from 2,300 theaters in its ...
Onasemnogene abeparvovec, sold under the brand name Zolgensma, is a gene therapy used to treat spinal muscular atrophy (SMA), [6] [7] a disease causing muscle function loss in children. It involves a one-time infusion of the medication into a vein . [ 6 ]
Pages for logged out editors learn more. Contributions; Talk; Breakthrough therapy designation
Fast track is one of five FDA approaches to make new drugs available as rapidly as possible: [1] the others are priority review, breakthrough therapy, accelerated approval and regenerative medicine advanced therapy. Fast track was introduced by the FDA Modernization Act of 1997. [2]
The Breakthrough is written for the lay reader and includes sections on immunology that have been written for a general audience. It examines the development of cancer immunotherapy, starting with William Coley's work with toxins in the 1890s, moving on to the long hiatus of immunotherapy, and concluding with victory for the believers in the form of regulatory approval of CTLA-4, PD-1, and PD ...
Suzetrigine, sold under the brand name Journavx, is a medication used for the management of pain. [1] [2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Na v 1.8-dependent pain-signaling pathways in the peripheral nervous system, [3] [4] avoiding the addictive potential of opioids.