Vanda Challenges FDA’s Denial Of Drug’s Fast-Track Application In High Court

( May 28, 2025, 8:05 AM EDT) -- WASHINGTON, D.C. — The U.S. Food and Drug Administration moved “the legal goalposts” when it denied a pharmaceutical company’s application for a fast-track approval of its new drug, and the District of Columbia Circuit U.S. Court of Appeals erred in finding that the decision was not arbitrary and capricious, the company argues in a petition for writ of certiorari filed in the U.S. Supreme Court....

Related Sections