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ALS

FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine …

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ALS

How a long shot ALS drug came before the FDA

The drug’s beginnings, according to the two former students there to see them, were quite humble. About a decade ago, Justin Klee and Josh Cohen …

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ALS

Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

Amylyx Pharmaceuticals has officially asked the Food and Drug Administration to approve its experimental and closely watched medicine for ALS. Now, the FDA has around …

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ALS

Biogen’s closely watched ALS drug comes up short in late-stage study

An experimental drug for amyotrophic lateral sclerosis missed the main goal of a late-stage clinical trial, marking another setback in attempts to treat the debilitating …

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ALS

Gene therapy developer gets chance at a comeback with Pfizer deal

Voyager’s first generation of gene therapies for ALS, Parkinson’s and Huntington’s disease, all now discontinued, relied on a direct infusion into brain tissue, an invasive …

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