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 ...

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

After telegraphing an investigation in November, the FDA has moved to restrict the use of bluebird bio’s gene therapy Skysona ...

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 ...

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

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne muscular dystrophy. U.S. distribution has been paused amid safety concerns.

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 ...

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 ...

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.

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