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FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

The new option follows trial results that showed larger motor‑function gains in infants at the higher dose.

Xenon to Present Topline X-TOLE2 Phase 3 Results in Focal Onset Seizures at 8 A.M. ET Today

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

Ocugen Completes Phase III Enrollment for OCU400 and Targets Q3 2026 Rolling BLA

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

Roivant’s Brepocitinib Succeeds in 52-Week Dermatomyositis Phase 3 as Companies Target 2026 FDA Filing

FDA Names George Tidmarsh Director of Center for Drug Evaluation and Research

Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure