STAT+: FDA to convene second panel of outside experts to review Amylyx Pharma’s ALS treatment
Amylyx Pharmaceuticals said Tuesday that the Food and Drug Administration is bringing together a panel of outside experts for a second time to review new data on the company’s experimental treatment for ALS.
The FDA’s decision to schedule a second advisory panel for the Amylyx drug, called AMX0035, is unusual, particularly during the same review period. The expert panel will meet on Sept. 7, Amylyx said.
