US may speed approval of “breakthrough” drugs

WASHINGTON, May 10: Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to US approval, under a proposal likely to become law this year. US drug regulators would be able to label such treatments “breakthrough” therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients. (agencies)