The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s.
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…
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?
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.
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 agency’s own outside advisers …