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 Third Circuit Affirms Denial of Stelara Biosimilar Injunction pharminent May 11, 2026 Regulatory Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher pharminent May 11, 2026 Regulatory BMS’ Sotyktu secures EC approval for psoriatic arthritis pharminent May 11, 2026
