Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Regenxbio Appeals FDA CRL for MPS II Gene Therapy RGX-121
Regenxbio has filed an appeal with the US FDA over the complete response letter (CRL) issued for RGX-121, its gene therapy for mucopolysaccharidosis type II (MPS II; Hunter syndrome) partnered with Nippon Shinyaku. The US biotech said in its earnings…
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