The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine the Hatch-Waxman fra...
Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awaited clarity to regul...
The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how those decisions could ...
FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.
Eli Lilly reports favorable efficacy data on its investigational oral GLP-1 receptor agonist orforglipron, showing significantly greater reductions in...
FDA commissioner Marty Makary defends the agencys scientific standards and personnel, particularly CBER director Vinay Prasad, amid mounting political...
FDA awards Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for certain adults with unresectable or metastatic...
FDA prepares to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality reviews ahead of schedule.
