Medical Innovation Exchange

Genomics

FDA Approves Second Indication for Casgevy Cell-based Gene Therapy

FDA Approves Second Indication for Casgevy Cell-based Gene Therapy     On January 16, the FDA approved Casgevy from Vertex, a cell-based gene therapy, for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia (TDT), an inherited disorder characterized by life-long anemia requiring frequent blood transfusions. To produce Casgevy, patients’ hematopoietic (blood) …

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FDA Announces New Genetic Metabolic Advisory Committee

FDA Announces New Genetic Metabolic Advisory Committee     The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for the diagnosis, prevention or treatment of genetic metabolic diseases under the purview of the Division of Rare …

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