Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025

Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its October 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text…, Positive recommendations on new medicines, Brinsupri International non-proprietary name (INN) brensocatib Marketing authorisation applicant Insmed Netherlands B.V. Therapeutic indication Treatment of…, Wayrilz International non-proprietary name (INN) rilzabrutinib Marketing authorisation applicant Sanofi B.V. Therapeutic indication For the treatment of…, Negative recommendation on new medicine, Rezurock INN belumosudil Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of chronic graft-versus-host disease (…, Outcome of re-examination on recommendation for new medicine, Austedo INN deutetrabenazine Marketing authorisation applicant Teva GmbH Therapeutic indication Treatment of tardive dyskinesia More information Austedo:…, Positive recommendations on extensions of therapeutic indications , Breyanzi INN lisocabtagene maraleucel / lisocabtagene maraleucel  Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information…, Cejemly INN sugemalimab Marketing authorisation holder Cstone Pharmaceuticals Ireland Limited More information Cejemly: pending EC decision, Gazyvaro INN obinutuzumab Marketing authorisation holder Roche Registration GmbH More information Gazyvaro: pending EC decision, Libtayo INN cemiplimab Marketing authorisation holder Regeneron Ireland Designated Activity Company (DAC) More information Libtayo: pending EC decision, Paxlovid INN nirmatrelvir / ritonavir Marketing authorisation holder Pfizer Europe MA EEIG More information Paxlovid: pending EC decision, Pyrukynd INN mitapivat Marketing authorisation holder Agios Netherlands B.V. More information Pyrukynd: pending EC decision, Tremfya INN guselkumab Marketing authorisation holder Janssen Cilag International More information Tremfya: pending EC decision, Scemblix INN asciminib Market authorisation holder Novartis Europharm Limited More information Scemblix: pending EC decision, Withdrawal of initial marketing authorisation application, Hydrocortisone Aguettant INN hydrocortisone Market authorisation applicant Laboratoire Aguettant Therapeutic indication Prevention of bronchopulmonary…, Public-health recommendation, Oxbryta INN voxelotor Market authorisation applicant Pfizer Europe MA EEIG More information EMA confirms suspension of sickle cell disease medicine Oxbryta, , Other updates Start of Union reviews adopted during the CHMP meeting of 13-16…