Regulatory Biogen Bounces Back With FDA Nod for High-Dose Spinal Muscular Atrophy Drug BioSpaceThe FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.RegulatoryRare DiseaseRead full story pharminent March 30, 2026 (Last updated: March 30, 2026) BioSpace The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns. RegulatoryRare DiseaseRead full story Post navigation Previous: Biogen’s Lupus Drug Reduces Disease Activity, Further Deresking I&I PipelineNext: Kardigan Blood Pressure Drug Proves Hypothesis Despite Split Phase 2 Readout Related Stories Regulatory Ultragenyx wins FDA approval for first treatment targeting root cause of GSDIa pharminent August 20, 2026 Regulatory Regeneron wins FDA approval to challenge Ipsen for rare bone disease market pharminent August 20, 2026 Regulatory FDA grants accelerated approval to Ultragenyx’s Genglycos gene therapy pharminent August 20, 2026
