Posted by Michael Wonder on 29 Jun 2024
Rocket Pharmaceuticals provides regulatory update on Kresladi (marnetegragene autotemcel)
28 June 2024 - Rocket Pharmaceuticals today announced a regulatory update for Kresladi (marnetegragene autotemcel), a lentiviral vector-based gene therapy to treat severe leukocyte adhesion deficiency-I.
The US FDA has issued a complete response letter in response to Rocket’s biologics license application for Kresladi wherein the FDA requested limited additional Chemistry Manufacturing and Controls information to complete its review.
