approval

Breakthrough Alzheimer’s drug earns accelerated FDA approval

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Breakthrough Alzheimer’s drug earns accelerated FDA approval

A new, breakthrough drug designed to aggressively treat Alzheimer’s disease was awarded accelerated approval by the Food and Drug Administration on Friday. Leqembi — developed by Tokyo-headquartered Eisai — has been shown in trials to slow the cognitive and functional decline of people in the early stages of the illness. The accelerated approval comes amid … Read more

Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval

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Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval

A much-debated drug for Lou Gehrig’s disease won US approval on Thursday from the Food and Drug Administration. The nod represents a long-desired victory for patients, though it is likely to renew questions about the scientific rigor behind government reviews of experimental medicines, as the Associated Press has reported.  The FDA approved the drug from Amylyx Pharmaceuticals based … Read more