Approval makes it the first and only therapy in the EU indicated for both acute and chronic hepatitis C, supported by Phase 3 data
Researchers emphasized that the benefit persisted well beyond the treatment period, reinforcing the clinical rationale for time-limited therapy in selected patients
The study enrolled 639 patients, nearly 80% of whom had previously received a covalent BTK inhibitor
The decision was driven by results from the Phase III CAPItello-281 trial,
The regulatory decision follows promising results from RIVER-81
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
The company gets access to Lonza’s clinically validated SYNtecan linker-payload platform as it prepares an IND filing for its acute myeloid leukemia therapy in 2027
The move makes EBGLYSS the only therapy offering as few as six maintenance injections per year
The company said data from multiple VESPER studies show the peptide delivered meaningful weight loss, favorable tolerability, and the possibility of a first-in-class monthly injection format
The company will present 21 oral and poster presentations spanning investigational and approved therapies
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