Posted by Michael Wonder on 24 Sep 2025
Biogen provides regulatory update on high dose regimen of nusinersen
23 September 2023 - Biogen today announced that the US FDA issued a complete response letter for the Company’s supplemental new drug application for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy.
The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls module of the supplemental new drug application.
