FDA Alerts

FDA grants fast track designation to AAV-CNGA3 gene therapy for achromatopsia

The U.S. Food and Drug Administration has granted fast track designation to AAV-CNGA3 (MeiraGTx Holdings Plc) gene therapy for the treatment of achromatopsia (ACHM) caused by mutations in the CNGA3 gene, according to a press release. AAV-CNGA3 is designed to restore cone function, delivered to the cone receptors at the back of...