The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study,
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections
The decision marks a key step in the centralized EU review process
SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio
The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states
ENFLONSIA is a long-acting monoclonal antibody designed to shield infants through a typical five-month RSV season with a single, fixed dose
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