Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Places Clinical Hold on MPS Gene Therapies: Regenxbio/Nippon Shinyaku
The US FDA has issued a clinical hold on two gene therapies for mucopolysaccharidosis (MPS) being developed by Regenxbio — with Nippon Shinyaku as the strategic partner — after a brain tumor case was identified in one pediatric trial participant.…
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