In the past three decades the field of gene therapy has made remarkable progress surging from mere laboratory experiments to FDA-approved products which bring significant reduction in disease burden to patients who previously had no therapeutic options for their serious conditions.

In this paper it’s reviewed the evolution of the gene therapy clinical research landscape and described the gene therapy product development programs evaluated by the Food and Drug Administration in Investigational New Drug applications received in 1988 – 2019.

It’s also discussed the clinical development programs of the first six oncolytic and gene therapy products approved in the United States.