Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026

Twelve new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.The committee…, CHMP statistics Key figures from the July 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Evlarco International non-proprietary name (INN) obicetrapib / ezetimibe  Marketing authorisation applicant A. Menarini International Licensing S.A.…, Icotyde INN icotrokinra hydrochloride  Marketing authorisation applicant Janssen-Cilag International N.V. Therapeutic indication Treatment of moderate to…, Lynavoy INN linerixibat Marketing authorisation applicant Glaxosmithkline Trading Services Limited Therapeutic indication Treatment of cholestatic pruritus in…, Lyrokaul INN lerodalcibep Marketing authorisation applicant LIB Therapeutics B.V. Therapeutic indication Treatment of adults with primary…, Nezglyal INN leriglitazone  Marketing authorisation applicant Minoryx Therapeutics S.L. Therapeutic indication Treatment of cerebral…, Susvimo INN ranibizumab Marketing authorisation applicant Roche Registration GmbH Therapeutic indication Treatment of adults with neovascular (wet) age-…, Ubeslo INN obicetrapib Marketing authorisation applicant A. Menarini International Licensing S.A. Therapeutic indication Treatment of primary…, Zokovea INN ensitrelvir Marketing authorisation applicant Shionogi B.V. Therapeutic indication Post-exposure prophylaxis of COVID-19 More information…, Positive recommendation on new biosimilar medicine, Cavoley INN pegfilgrastim Marketing authorisation applicant CuraTeQ Biologics s.r.o Therapeutic indication Reduction of neutropenia in adults More…, Positive recommendations on new generic medicines, Riociguat Accord INN riociguat Marketing authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of Chronic thromboembolic…, Ruxolitinib Viatris INN ruxolitinib hemifumarate  Marketing authorisation applicant Viatris Limited Therapeutic indication Treatment of myelofibrosis (…, Tafamidis Accord INN tafamidis  Marketing authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of hereditary transthyretin…, Negative recommendations on new medicines, KemSu INN sufentanil / ketamine Marketing authorisation applicant Proveca Pharma Limited Therapeutic indication Treatment of acute pain in children aged 1 to…, Meplyffa INN arimoclomol citrate Marketing authorisation applicant Zevra Denmark A/S Therapeutic indication Treatment of Niemann-Pick disease type C in…, Qezzaqar INN catequentinib Marketing authorisation applicant CATS Consultants GmbH Therapeutic indication Treatment of synovial sarcoma or leiomyosarcoma…, Positive recommendations on extensions of therapeutic indications , Enhertu INN trastuzumab deruxtecan  Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu : pending EC decision, Jivi INN damoctocog alfa pegol Marketing authorisation holder Bayer AG More information Jivi : pending EC decision - to be published shortly , Piqray INN alpelisib Marketing authorisation holder Novartis Europharm Limited More information Piqray : pending EC decision, Repatha INN evolocumab  Marketing authorisation holder Amgen Europe B.V. More information Repatha : pending EC decision, Rinvoq INN upadacitinib Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG. More information Rinvoq : pending EC decision, Riltrava Aerosphere INN formoterol / glycopyrronium bromide / budesonide  Marketing authorisation holder AstraZeneca AB More information Riltrava…, Trixeo Aerosphere INN formoterol / glycopyrronium bromide / budesonide  Marketing authorisation holder AstraZeneca AB More information Trixeo…, Trodelvy INN sacituzumab govitecan  Marketing authorisation holder Gilead Sciences Ireland Unlimited Company More information Trodelvy : pending EC…, Withdrawal of application for recommendation on new medicine, Azacitidine Adienne INN azacitidine More information Azacitidine Adienne : Withdrawal, Withdrawal of applications for recommendations on extensions of indications , Dupixent INN dupilumab  More information Dupixent : Withdrawal, Imfinzi INN durvalumab More information Imfinzi : Withdrawal, Other updates, Overview of (invented) names reviewed in June 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 23 July 2026Adopted…