Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026

Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.The committee recommended…, CHMP statistics Key figures from the June 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Aujemflu Common name Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated  Marketing authorisation applicant Seqirus Netherlands…, Hopledo INN levodopa / carbidopa  Marketing authorisation applicant Zambon S.p.A. Therapeutic indication Treatment of adult patients with Parkinson’s…, Onswik INN insulin efsitora alfa  Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of type 2 diabetes…, Positive recommendations on new biosimilar medicines, Denosumab Ascend INN denosumab Marketing authorisation applicant Ascend GmbH Therapeutic indication Prevention of skeletal related events and treatment of…, Nylaspeg INN pegfilgrastim Marketing authorisation applicant Qilu Pharma Spain S.L. Therapeutic indication Reduction of neutropoenia in adults More…, Positive recommendation on re-examination of new medicine, Daybu INN trofinetide Marketing authorisation applicant Acadia Pharmaceuticals (Netherlands) B.V. Therapeutic indication Daybu is indicated for the treatment…, Negative recommendations on new medicines, Tacquell INN autologous melanoma-derived tumour infiltrating lymphocytes, ex vivo-expanded  Marketing authorisation applicant Netherlands Cancer Institute…, Yartemlea INN narsoplimab  Marketing authorisation applicant Omeros Ireland Limited Therapeutic indication Treatment of patients with haemopoietic stem…, Xervyteg INN allogeneic faecal microbiota, pooled  Marketing authorisation applicant MaaT PHARMA Therapeutic indication Treatment of adult patients with…, Positive recommendations on extensions of therapeutic indications , Datroway INN datopotamab deruxtecan  Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Datroway : pending EC decision, Imvanex Common name smallpox and monkeypox vaccine (live modified vaccinia virus Ankara) Marketing authorisation holder Bavarian Nordic A/S More information…, Ixchiq Common name Chikungunya vaccine (live) Marketing authorisation holder Valneva Austria GmbH More information Ixchiq : pending EC decision, Jaypirca INN pirtobrutinib Marketing authorisation holder Eli Lilly Nederland B.V. More information Jaypirca : pending EC decision, Leqvio INN inclisiran Marketing authorisation holder Novartis Europharm Limited More information Leqvio : pending EC decision, MenQuadfi Common name Meningococcal Group A, C, W and Y conjugate vaccine   Marketing authorisation holder Sanofi Winthrop Industrie More information…, Opzelura Common name ruxolitinib  Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Opzelura : pending EC decision, Rezolsta INN darunavir / cobicistat   Marketing authorisation holder Janssen Cilag International More information Rezolsta : pending EC decision, Rinvoq INN upadacitinib   Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG More information Rinvoq : pending EC decision (VR-…, Stelara INN ustekinumab Marketing authorisation holder Janssen Cilag International More information Stelara : pending EC decision, Symtuza INN darunavir / cobicistat / emtricitabine / tenofovir alafenamide Marketing authorisation holder Janssen Cilag International More information…, Tecvayli INN teclistamab Marketing authorisation holder Janssen-Cilag International N.V. More information Tecvayli : pending EC decision, Start of referral procedure, Rifadin oral suspension and syrup and associated names INN rifampicin  More information Rifadin oral suspension and syrup and associated names : referral, Conclusion of referral procedure, Tavneos INN avacopan  More information Tavneos : referral News EMA recommends revoking marketing authorisation for Tavneos , Other updates, Start of Union reviews adopted during the CHMP meeting of 22-25 June 2026 English (EN) (104.89 KB - PDF)First published: 26/06/…