The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
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
Clearance marks major shift beyond chemotherapy
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 recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
If approved, TEV-‘749 would mark a shift toward long-acting care aimed at improving treatment adherence in real-world settings
The decision marks a key step in the centralized EU review process
The company is also highlighting early-stage innovation in antibody-drug conjugates and in vivo CAR-T therapy
The company said the breadth of its showcase reflects “progress from its differentiated oncology pipeline in solid tumors and hematologic malignancies,”
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