WASHINGTON--When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval?...
That’s the question behind many of the Food and Drug Administration’s toughest decisions, including last year's controversial approval of Aduhelm....
The FDA meets next week to publicly review evidence from a small, mid-stage study of Amylyx Pharmaceuticals’ drug for ALS, or amyotrophic lateral sclerosis. Regulators tol
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2022-03-24 00:00:00.0