D.C. Circuit Upholds FDA’s Summary Judgment In Generic Drug Approval Case

( September 29, 2025, 1:58 PM EDT) -- WASHINGTON, D.C. — Novartis Pharmaceuticals Corp.’s arguments on appeal, disputing a district court judge’s denial of its motion for summary judgment in a case contesting the U.S. Food and Drug Administration’s approval of a generic version of its heart failure drug Entresto, gave the District of Columbia Circuit U.S. Court of Appeals “no reason to question the FDA’s expert judgment regarding these scientific issues,” the court said in a Sept. 26 opinion....