Inside FDA’s New Gene and Cell Therapy Guidances

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.