FDA decision on lovo-cel for SCD now expected by year’s end

The U.S. Food and Drug Administration (FDA) is expected to decide before year’s end on whether or not to approve the experimental gene therapy lovotibeglogene autotemcel — known as lovo-cel — for people with sickle cell disease (SCD) who have a history of painful vaso-occlusive crises (VOCs). The…

FDA grants exa-cel priority review, with decision due by year’s end

The U.S. Food and Drug Administration (FDA) is reviewing an application that seeks the approval of exagamglogene autotemcel, a CRISPR-based gene-editing therapy known as exa-cel, to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia. The rolling biologics license application was completed by Vertex Pharmaceuticals and CRISPR…