News

Medscape7m
FDA Approves First One-Time Topical Treatment for Recessive Dystrophic Epidermolysis Bullosa Wounds
In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...
Healio4h
FDA approves Zevaskyn for treatment of recessive dystrophic epidermolysis bullosa
The FDA has approved Zevaskyn for the treatment of recessive dystrophic epidermolysis bullosa, the company announced in a ...
Asianet Newsable on MSN53m
Abeona Therapeutics’ Gene Therapy Gets FDA Nod For Treating Rare Genetic Skin Disease
ZEVASKYN is expected to be available beginning in the third quarter of 2025 through ZEVASKYN Qualified Treatment Centers, ...
BioPharma Dive3h
Abeona cell therapy approved by FDA for rare skin condition
Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal ...
MPR1h
Zevaskyn Approved for Recessive Dystrophic Epidermolysis Bullosa
The FDA has approved Zevaskyn (prademagene zamikeracel) for the treatment of recessive dystrophic epidermolysis bullosa, a rare genetic skin disorder.
The American Journal of Managed Care2h
FDA Approves Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa
Prademagene zamikeracel (Zevaskyn) is the first and only cell-based gene therapy for wound treatment in patients with ...
US FDA approves first cell-based gene therapy for rare genetic skin disorder
The U.S. Food and Drug Administration approved Abeona Therapeutics' gene therapy for a rare skin disorder on Tuesday. The ...
Crain's Cleveland Business47m
Cleveland company receives FDA approval for rare disease treatment
Cleveland-based Abeona Therapeutics Inc. (Nasdaq: ABEO) announced Tuesday, April 29, that it has received U.S. Food and Drug Administration (FDA) approval for a cell-based gene therapy that treats a ...
Fierce Pharma4h
Abeona enters commercial gene therapy arena with FDA nod for Zevaskyn to treat rare genetic skin disease
Persistence has paid off for Abeona Therapeutics and its gene therapy for recessive dystrophic epidermolysis bullosa (RDEB).
First Cell-Based Gene Therapy Approved for Rare Skin Disorder
The US Food and Drug Administration (FDA) has approved the first cell-based gene therapy for a rare genetic skin disorder.
Historic achievement: FDA approval of Abeona Therapeutics' ZEVASKYN accelerates momentum and expands treatment options for the EB community.
In a significant advancement for the Recessive Dystrophic Epidermolysis Bullosa (RDEB) community, the U.S. Food and Drug ...
BioSpace4h
Abeona Gets FDA Nod for Rare Skin Disease Gene Therapy
The condition, recessive dystrophic epidermolysis bullosa, causes chronic wounds and has an 84% mortality rate by age 40.