The European Medicines Agency’s human medicines committee recommended marketing authorisations for Aumseqa (aumolertinib) and Zybrivo (sintilimab), both for non-small cell lung cancer, and for Baxfendy (baxdrostat) for hypertension that is not sufficiently controlled, alongside two insulin aspart biosimilars for diabetes and two generics. The committee also backed wider uses for 11 authorised medicines, including Gazyvaro for moderate to severe active systemic lupus erythematosus, and confirmed after re-examination its refusal of KemSu for acute pain in children and of Meplyffa for Niemann-Pick disease type C. Two applications, Amlypave for cardiac light chain amyloidosis and Qezzaqar for soft tissue sarcoma, were withdrawn.
EMA committee recommends seven new medicines for approval
The European Medicines Agency's CHMP recommended seven new medicines for approval at its November 9 to 12 meeting, including Baxfendy (baxdrostat) for insufficiently controlled hypertension and two lung cancer medicines, Aumseqa and Zybrivo.
Why it matters: A positive CHMP opinion is the last scientific step before a European Commission marketing authorisation, so the seven recommendations, plus extended uses for 11 existing medicines including Gazyvaro in lupus, set the next round of EU drug launches and label expansions.
Data as of European Medicines Agency, CHMP meeting highlights for 9 to 12 November 2026, published November 13, 2026 and read in full. Developing item.
Sources
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2026 - European Medicines Agency - 2026-11-13