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...
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug approvals in multip...
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.
