D.C. Circuit: Once an orphan, always an orphan – at least in the past Aug. 18, 2020 By Mari Serebrov No Comments The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc rehearing of Eagle Pharmaceuticals Inc. v. Alex Azar.Read More