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NewsFDAMonday, December 8, 2025 · December 8, 2025

FDA Approves First Gene Therapies for Sickle Cell Disease

WHY IT MATTERS

First CRISPR-based therapy ever approved. Opens door for gene editing across rare diseases.

The FDA approved Casgevy and Lyfgenia, the first cell-based gene therapies for sickle cell disease. Casgevy is the first FDA-approved therapy utilizing CRISPR/Cas9 gene editing.

Read the original at FDA
FDA ApprovalGene Therapy

Related conditions

Sickle cell disease