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 Bayer’s Hyrnuo set for the NSCLC frontlines on accelerated FDA label expansion pharminent September 10, 2026 Regulatory HHS appoints permanent FDA CBER, CDER heads pharminent September 10, 2026 Regulatory FDA approves AstraZeneca’s Etcamah combo for advanced breast cancer pharminent September 7, 2026