Why Biohaven will test the FDA’s regulatory limits  

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

I love a good regulatory debate. Biohaven Pharmaceuticals has given us a new one to chew over. 

advertisement

On Monday, the company said it planned to submit a marketing application to the Food and Drug Administration before the end of the year, seeking approval for an experimental drug called troriluzole to delay progression of spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease.

STAT+ Exclusive Story

STAT+

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

Already have an account? Log in

View All Plans

To read the rest of this story subscribe to STAT+.

Subscribe