FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune disease with no approved treatments.
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune disease with no approved treatments.
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.
