ENFLONSIA is a long-acting monoclonal antibody designed to shield infants through a typical five-month RSV season with a single, fixed dose
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
RSM01, a preventive treatment targeting respiratory syncytial virus (RSV), was licensed earlier this month from the Gates Medical Research Institute
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers
Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients
The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials
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