Cat­a­lyst wins re­ver­sal in or­phan ex­clu­siv­i­ty court bat­tle with FDA

A US appeals court on Thursday afternoon overturned a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but pricey drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Read the source article at endpts.com
2021-10-01 10:59:43