FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More

January 11, 2019 – The FDA’s Fast Track program is designed to facilitate the development of new treatments for serious or life-threatening conditions for which there is a significant unmet medical need. A therapeutic agent that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly … (leggi tutto)