Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Spinraza under PMDA Risk Review for Hydrocephalus
The Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing the risk of hydrocephalus for Biogen Japan’s spinal muscular atrophy (SMA) treatment Spinraza (nusinersen) - a move that is likely to result in label changes - according to the agency’s risk…
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