FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each goal.
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each goal.
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
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 significant efficacy in reducing moderate and severe exacerbations in certain patients with chronic obstructive pulmonary disease.
Former FDA chief counsel Mark Raza joins Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology practice.