FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) for leukocyte adhesion deficiency type I, according to the company’s March approvals update. FDA also issued a rare pediatric disease priority review voucher tied to the approval. The therapy is described as delivering MAC-1 using an autologous cell approach. Rocket said its first product is expected to launch by year-end, setting up a commercialization timeline for the company’s lead program. The approval marks what Rocket characterized as the first BLA to pass CBER this year, underscoring continued regulatory momentum for gene therapies targeting rare pediatric genetic diseases.