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

Update as of 18 May 2026'CHMP statistics' graphic - updated figures for total negative opinions on new medicines and for positive opinions on extensions of therapeutic…, CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Cenrifki INN tolebrutinib Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of non-relapsing secondary progressive…, Itvisma INN onasemnogene abeparvovec Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of 5q spinal muscular…, Redemplo INN plozasiran Marketing authorisation applicant Arrowhead Pharmaceuticals Ireland Limited Therapeutic indication Treatment of familial…, Positive recommendations on new biosimilar medicine, Rexatilux INN ranibizumab Marketing authorisation holder Intas Third Party Sales 2005 S.L. Therapeutic indication Treatment of adults with neovascular (wet)…, Positive recommendations on new generic medicine, Palbociclib Viatris INN palbociclib Marketing authorisation holder Viatris Limited Therapeutic indication Treatment of breast cancer More information…, Positive recommendations on extensions of therapeutic indications , Agamree INN vamorolone Marketing authorisation holder Santhera Pharmaceuticals (Deutschland) GmbH More information Agamree: pending EC decision, Aquipta INN atogepant Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Aquipta: pending EC decision, Comirnaty INN COVID-19 mRNA vaccine Marketing authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: pending EC decision, Crysvita INN burosumab Marketing authorisation holder Kyowa Kirin Holdings B.V. More information Crysvita: pending EC decision, Inaqovi INN decitabine / cedazuridine Marketing authorisation holder Otsuka Pharmaceutical Netherlands B.V. More information Inaqovi: pending EC decision, Opdivo INN nivolumab Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Opdivo: pending EC decision, Privigen INN human normal immunoglobulin Marketing authorisation holder CSL Behring GmbH More information Privigen: pending EC decision, Skyrizi INN risankizumab Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Skyrizi: pending EC decision, Venclyxto INN venetoclax Marketing authorisation holder Abbvie Deutschland GmbH & Co. KG More information Venclyxto: pending EC decision (EMA/VR/…, Withdrawal of initial marketing authorisation application, Viokat INN diazoxide choline Marketing authorisation applicant Soleno Therapeutics Europe Limited Therapeutic indication Treatment of adult and paediatric…, Withdrawal of application to change the marketing authorisation, Pluvicto INN lutetium (177Lu) vipivotide tetraxetan Marketing authorisation holder Novartis Europharm Limited More information Pluvicto: questions and answers…, Other updates Questions and answers on the outcome of assessment on use of Opdualag…