FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune dise...
FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.
FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally advanced or metastatic ...
Rezolute says FDA is still reviewing the additional data the agency requested from the companys Phase 3 sunRIZE trial of ersodetug to treat hypoglycem...
FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision restoration in patie...
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...
