Vinay Prasad is returning to his role at the U.S. Food and Drug Administration to resume overseeing vaccine, gene therapy and ...

The FDA approved labeling changes for elivaldogene autotemcel (eli-cel; Skysona), a one-time gene therapy for patients with ...

The primary safety risks associated with gene therapy include immune reactions and off-target effects in unintended organs, ...

Gene therapy appears to be a promising approach for a subset of genetic deafness, although challenges remain with development ...

A 26-year-old Downriver man seen at Children’s Hospital of Michigan in Detroit since infancy for a rare bleeding disorder in ...

For nearly three decades, Mayo Clinic researcher Christopher Evans, Ph.D., has pushed to expand gene therapy beyond its ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Leveraging Northway Biotech’s 20+ years of CDMO expertise, Diorasis Therapeutics is advancing AAV gene therapy for glaucoma ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators ...

The first gene therapy product approved by the Food and Drug Administration (a treatment for a form of leukemia, approved last summer) costs hundreds of thousands of dollars for each infusion.

Michael Carducci, M.D., Professor, Johns Hopkins Kimmel Cancer Center Jan. 01, 2009 -- Question: What is the difference between gene therapy and immunotherapy, and can either or both be combined ...

Vinay Prasad is returning to his role at the U.S. Food and Drug Administration, a little more than a week after he had left ...