Key Takeaways Biogen got an FDA CRL for its sNDA seeking approval of a higher-dose regimen of Spinraza.The FDA requested CMC updates, with no deficiencies flagged in clinical data for the higher dose.EMA and other regulators are reviewing filings, and Japan has already approved the higher dose.Biogen (BIIB) announced that the FDA has issued a complete response letter (CRL) to its supplemental new drug application (sNDA) seeking label expansion for a higher dose of its renowned spinal muscular atrophy (SMA) ...