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 Scholar Rock’s muscle-targeting SMA therapy Isemblyd lands FDA approval pharminent September 14, 2026 Regulatory Psychedelic therapies ride wave of public favor into FDA hearing pharminent September 14, 2026 Regulatory Bayer’s Hyrnuo set for the NSCLC frontlines on accelerated FDA label expansion pharminent September 10, 2026