Posted by Michael Wonder on 07 Nov 2025
The FDA is a mess, but don’t blame it for everything
6 November 2025 - Biohaven and Uniqure fault agency volatility for setbacks. The reality may be more complicated.
The FDA was more than likely correct to reject Biohaven Pharmaceuticals’ treatment for spinocerebellar ataxia, a rare and debilitating neurodegenerative disease. At the very least, the decision announced Tuesday night was not a surprise to anyone paying attention. Approval was a coin flip, at best.
