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FDA Grants Regenxbio Priority Review for MPS II Gene Therapy Regulatory Application
The FDA will issue a decision on the BLA for RGX-121 by November, which if positive, could make it the first gene therapy for Hunter syndrome.
Trump Signs Executive Order on Matching US Drug Costs to Lower Prices Abroad
In his first term, pharmaceutical companies took the "most favored nation" policy to court over the White House's effort to slash costs for patients.
Genomate Health Raises $2M, Enters US Market With Precision Oncology Clinical Decision Support Tool
The company plans to bring its genomics-based precision oncology drug selection platform to US healthcare systems.
FDA Clears Ensoma's IND to Launch Immune Disorder Gene Therapy Trial
EN-374 is a gene therapy designed to treat X-linked chronic granulomatous disease by modifying hematopoietic stem cells in vivo.
From decoy DNA sequences to plasmapheresis, researchers are testing strategies to get around anti-AAV antibodies that hinder gene therapy response.