News

FDA Recommends Abeona’s EB-101 Gene Therapy to Advance Toward Phase 3 Trial

The U.S. Food and Drug Administration (FDA) recently recommended Abeona Therapeutics accelerate the clinical development program of its gene therapy candidate EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), also known as “butterfly skin” syndrome. With the recommendation, which came in a recent Type-C meeting with the…

FDA Grants Rare Pediatric Disease Designation to EB-101 as a Treatment for Blistering Skin Disorder

The U.S. Food and Drug Administration has granted a Rare Pediatric Disease Designation to EB-101,  Abeona Therapeutics’ treatment for the inherited skin disease epidermolysis bullosa, or EB. Importantly, the designation also covers a severe form of the blistering and open-wound disorder known as recessive dystrophic epidermolysis bullosa, or RDEB. The FDA…