EMA Recommends Approval for Seven New Medicines and Expands Indications for Eleven Others

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for seven new medicines during its November 2026 meeting. These include Aumseqa (aumolertinib) for non-small cell lung cancer, Baxfendy (baxdrostat) for hypertension, and Zybrivo (sintilimab) for non-squamous non-small cell lung cancer. Additionally, the CHMP adopted positive opinions for two biosimilar medicines for diabetes (Garzulys and Donrafylix) and two generic medicines (Fondaparinux sodium Evumed and Ruxolitinib Krka). The committee also recommended extending the therapeutic indications for 11 existing medicines.