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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 people aged twelve years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy [2]
An experimental medication may slow the progression of amyotrophic lateral sclerosis, or ALS, researchers reported Wednesday. The research was supported in part by donations from the Ice Bucket ...
Non-invasive ventilation (NIV) is the primary treatment for respiratory failure in ALS [10] and was the first treatment shown to improve both survival and quality of life. [5] NIV uses a face or nasal mask connected to a ventilator that provides intermittent positive pressure to support breathing.
Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrig’s disease at a Wednesday meeting prompted by years of patient efforts seeking access to the unproven ...
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]
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In March 2024, Amylyx Pharmaceuticals announced that its Phase III PHOENIX clinical trial of 664 American and European adults followed over 48 weeks showed no statistically significant difference in the functioning of ALS patients that were randomly assigned to treatment with Relyvrio, as compared to those receiving a placebo drug.
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