Washington Post, September 29, 2022: FDA approves new ALS drug for Lou Gehrig’s disease despite NCHR and other experts’ criticisms that the drug’s effectiveness is questionable and FDA evidence standards should be higher.
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NCHR Testimony by Dr. Diana Zuckerman about AMX0035 for ALS at FDA Advisory Committee
March 30, 2022. ALS is a devastating disease and all of us want better treatments to be available as soon as possible. But NCHR agrees with FDA that “The secondary endpoint results are not compelling or supportive of the primary endpoint.”
Read More »FDA advisers to discuss ALS drug at Wednesday meeting
Politico, March 29, 2022. On March 30, FDA holds a highly anticipated advisory committee on neurological drugs to discuss a drug from Amylyx that aims to treat amyotrophic lateral sclerosis (ALS). Dr. Diana Zuckerman told Politico: “Did the FDA schedule an advisory committee meeting to placate patient advocates and other political pressure in the hope that the advisory committee would vote against it? Or is the FDA really considering approving it?”
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