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.
An FDA Voices post by FDA chief operating officer Barclay Butler says the agencys ability to uphold the gold standard of regulatory review depends as ...
A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility and a drop in advisory...
