Posted by Michael Wonder on 12 Nov 2024
Abeona Therapeutics announces FDA acceptance of BLA resubmission of prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis bullosa
12 November 2024 - Abeona Therapeutics today announced that the US FDA has accepted for review Abeona’s resubmission of its biologics license application for prademagene zamikeracel, its investigational autologous cell based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa.
The FDA has assigned a PDUFA target action date of 29 April 2025.
