FDA grants breakthrough therapy designation for UCBs Cimzia in some pregnant women with antiphospholipid syndrome.
The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each goal.
AstraZeneca reports data from the Phase 3 OBERON and TITANIA trials showing that tozorakimab is the first biologic to demonstrate statistically signif...
Former FDA chief counsel Mark Raza joins Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology practice.
FDA issues a guidance entitled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates that is intended to ...
FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
FDA solicits public comment on a proposed study to learn from healthcare providers their understanding of barriers to higher patient enrollment in pre...
