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In the last year, the FDA has approved two new drugs for ALS, after a nearly 20-year drought of new options. The approvals followed intense lobbying by advocacy groups.
That compromise would be similar to FDA's approach to Relyvrio last year, another ALS drug with questionable data. But in that case, the drugmaker had started its follow-up study long before approval.
(Reuters) -Advisers to the U.S. health regulator on Wednesday voted against BrainStorm Cell Therapeutics' therapy for a rare and fatal neurodegenerative disease called amyotrophic lateral ...
Amylyx Pharmaceuticals announced Friday that its drug for amyotrophic lateral sclerosis, or ALS, called Relyvrio, did not show significant benefit in a large clinical trial and may be withdrawn ...
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Riluzole was approved in the United States for the treatment of ALS by the U.S. Food and Drug Administration (FDA) in 1995. [6] A Cochrane Library review states a 9% gain in the probability of surviving one year.
Health reporter Anjalee Khemlani outlines the circumstances behind the FDA's approval of a new ALS treatment drug amid high drug prices.
Amylyx's ALS drug failed to get a recommendation from an FDA panel, which said the evidence wasn't strong enough to support the experimental drug.
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