• By ICR Secretariat
  • Posted Tuesday, September 20, 2022

How a top FDA official’s words helped push a closely watched ALS drug toward approval

https://www.biopharmadive.com/news/amylyx-fda-als-meeting-dunn-flexibility-withdrawal/631533/

The meeting was already unusual. Convened by the Food and Drug Administration Wednesday, a group of independent experts were, for a rare second time, gathering to review an experimental drug for ALS that has become the latest litmus test of the agency’s approval standards.