Approval of Gene Therapy Treatment for CALD Anticipated in September 2022

Lenti-D (elivaldogene autotemcel or eli-cel) is an investigational gene therapy being developed by bluebird bio for the treatment of childhood cerebral adrenoleukodystrophy (CALD). The FDA advisory committee reviewed it in June 2022 and unanimously approved drug/therapy 15-0. The FDA’s scheduled decision date on the therapy is September 16, 2022.

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Cell and Gene Therapies: Navigating a Challenging Landscape

Cell and gene therapy will most certainly continue to shift paradigms for manufacturers, patients, healthcare providers and pharmacies for many years. These are groundbreaking technologies which offer hope to millions of individuals that previously had no viable options for treatment or cure.

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