Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting.The committee recommended…, CHMP statistics Key figures from the March 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Adstiladrin INN nadofaragene firadenovec Marketing authorisation applicant Ferring Pharmaceuticals A/S Therapeutic indication Treatment of adult…, Imdylltra INN tarlatamab Marketing authorisation applicant Amgen Europe B.V Therapeutic indication Treatment of extensive-stage small cell lung cancer. More…, Joenja INN leniolisib Marketing authorisation applicant Pharming Technologies B.V. Therapeutic indication Treatment of activated phosphoinositide 3-…, Zepzelca INN lurbinectedin Marketing authorisation applicant Pharma Mar S.A. Therapeutic indication Maintenance treatment of adult patients with extensive-…, Positive recommendations on new hybrid medicines, Bopediat INN furosemide Marketing authorisation holder Proveca Pharma Limited Therapeutic indication Treatment of all conditions requiring diuresis due…, Positive recommendations on extensions of therapeutic indications , Besponsa INN inotuzumab ozogamicin Marketing authorisation holder Pfizer Europe MA EEIG More information Besponsa : pending EC decision, Capvaxive INN pneumococcal polysaccharide conjugate vaccine (21-valent) Marketing authorisation holder Merck Sharp & Dohme B.V. More information…, Feraccru INN ferric maltol Marketing authorisation holder Norgine B.V. More information Feraccru : pending EC decision, Hetronifly INN serplulimab Marketing authorisation holder Accord Healthcare S.L.U. More information Hetronifly: pending EC decision (EMA/VR/0000284402)…, Hympavzi INN marstacimab Marketing authorisation holder Pfizer Europe MA EEIG More information Hympavzi : pending EC decision, Imcivree INN setmelanotide Marketing authorisation holder Rhythm Pharmaceuticals Netherlands B.V. More information Imcivree : pending EC decision, Lojuxta INN lomitapide Marketing authorisation holder Chiesi Farmaceutici SpA More information Lojuxta : pending EC decision, Mekinist INN trametinib Marketing authorisation holder Novartis Europharm Limited More information Mekinist : pending EC decision (EMAVR0000271728)Mekinist…, Mresvia INN respiratory syncytial virus mRNA vaccine (nucleoside modified) Marketing authorisation holder Moderna Biotech Spain, S.L. More information…, Namuscla INN mexiletine hcl Marketing authorisation holder Lupin Europe GmbH More information Namuscla : pending EC decision, Retsevmo INN selpercatinib Marketing authorisation holder Eli Lilly Nederland B.V. More information Retsevmo : pending EC decision, Sotyktu INN seucravacitinib Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Sotyktu : pending EC decision, Tafinlar INN dabrafenib Marketing authorisation holder Novartis Europharm Limited More information Tafinlar : pending EC decision (EMAVR0000271728)Tafinlar…, Outcome of re-examination, Hetlioz INN tasimelteon Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Hetlioz, Withdrawal of application, Blarcamesine Anavex INN blarcamesine Marketing authorisation applicant Anavex Germany GmbH Therapeutic indication Treatment of Alzheimer’s disease…, Referral procedures, Tecovirimat SIGA INN tecovirimat More information Tecovirimat SIGA , Other updates, Sarclisa INN isatuximab Marketing authorisation holder Sanofi Winthrop Industrie More information Sarclisa : pending EC decision, Reflection paper on a tailored clinical approach in biosimilar developmentAdopted…