Posts

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

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In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy

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FDA Approves Denali Therapeutics' Avlayah for Hunter Syndrome, First Treatment for Neurologic Manifestations

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FDA Grants Accelerated Approval to Denali's Avlayah for Hunter Syndrome, Defying Rare Disease Rejection Trend

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REGENXBIO's Hunter Syndrome Gene Therapy RGX-121 Rejected by FDA

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FDA Action Alert: Upcoming Decisions on Sanofi/Regeneron, Merck, REGENXBIO and More in February 2026

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FDA Places Clinical Holds on Regenxbio's RGX-111 and RGX-121 Gene Therapy Trials After Brain Tumor in Patient

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FDA Delays Denali's Hunter Syndrome Therapy Decision by Three Months

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FDA Extends PDUFA Date for Regenxbio's Hunter Syndrome Gene Therapy RGX-121

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