The US Food & Drug Administration always emphasizes that it makes drug approval decisions based on a set of statutory standards that do not change.
Thoughts After Amylyx AMX0035 Committee: How Special Is ALS At FDA?
An advisory committee rejection of the proposed ALS therapy AMX0035 amounts to a vote in favor of US FDA’s approach to the review. It also amounts to an implicit rejection of the idea that ALS merits unique approaches given the devastating nature of the illness.
