Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival
The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy
The acquisition brings two commercialized, differentiated medicines—EMPAVELI and SYFOVRE —to Biogen’s growth portfolio
Efzimfotase alfa is an investigational enzyme replacement therapy designed to reduce injection volume
The CDMO Leadership Awards spotlight top-performing development and manufacturing service providers
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
The SCOUT-HCM trial hit its primary endpoint, showing a clinically meaningful and statistically significant reduction in Valsalva left ventricular outflow tract
The inspection is now closed, and no regulatory action has been recommended
The presentations underscore the company’s deep expertise in dermatology and immunology
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