Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Pushes Back Decision on Hunter Syndrome Gene Therapy
The US FDA has extended the review of clemidsogene lanparvovec (RGX-121), an investigational gene therapy for Hunter Syndrome, by three months to February 8, 2026. The product was developed and filed in the US by Regenxbio and is slated to…
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