FDA Fast Tracks Drug for Radiation Enteritis

DOR BioPharma has received FDA fast-track status for DOR201, which it is developing to prevent acute radiation enteritis, a side effect of radiation therapy for cancer, according to the company. In addition, the FDA has used its special protocol assessment procedure to approve DOR’s design of a separate Phase III clinical trial in which a different product with the same active ingredient is being studied as a treatment of acute gastrointestinal graft vs. host disease.
Washington Drug Letter