Biogen gets complete response letter from FDA for higher dose Spinraza

Core Insights - Biogen's request for supplemental marketing authorization for a higher dose of Spinraza has been declined by the U.S. FDA, indicating regulatory challenges for the company in expanding its treatment options for spinal muscular atrophy [5] Company Summary - The FDA's complete response letter to Biogen highlighted that the company needs to address specific concerns before any further consideration of the higher dose of Spinraza can occur [5]