CHMP opinion now expected in 1Q 2025No Major Objections outstanding; continue to expect Germany launch in 2Q 2025PITTSBURGH, Dec. 09, 2024 ...

The firm is on track to launch the gene therapy for dystrophic epidermolysis bullosa, called Vyjuvek in the US, in Germany in Q2 2025.

Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back: In Vlahovic's experience, KeryFlex and NECPro last 6-8 weeks.

The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for prademagene zamikeracel for the treatment of recessive dystrophic ...

as a potential new treatment for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025.

Prademagene zamikeracel (pz-cel) is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa.