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Food and Drug Administration (FDA) FDA Approval CRISPR

Goodwin

FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease

Goodwin on

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA.  SCD is a group of inherited...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

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