Speeding up the process
Today, August 3, 2017, Regeneron Pharmaceuticals reported earnings including an announcement that Regeneron has received Fast Track Designation from the U.S. Food & Drug Administration (FDA) for REGN 2477. Fast Track Designation allows for companies to have more frequent engagement with the FDA and allows a company to be eligible for accelerated approval/priority review (a 6-month review timeline). Only drugs being developed for serious, unmet medical conditions can receive Fast Track Designation. Congratulations to Regeneron for achieving this important milestone!