Under a recent law, the National Institutes of Health will begin spending about $25 million to enroll patients in open access programs of unapproved drugs.
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. Many experts — including the…
The Food and Drug Administration meets next week to review a closely watched drug for ALS, following months of lobbying by patient groups and lawmakers.