Fuente: EMA. News Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.The committee…, CHMP statistics Key figures from the December 2025 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Anktiva International non-proprietary name (INN) nogapendekin alfa inbakicept  Marketing authorisation applicant Serum Life Science Europe GmbH…, Aumseqa INN aumolertinib  Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication Treatment of non-small cell lung…, Exdensur INN depemokimab  Marketing authorisation applicant Glaxosmithkline Trading Services Limited Therapeutic indication For severe eosinophilic…, Myqorzo INN aficamten  Marketing authorisation applicant Cytokinetics (Ireland) Limited Therapeutic indication Treatment of symptomatic obstructive…, mNexspike INN COVID-19 mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Active immunisation to prevent COVID…, Positive recommendations on new biosimilar medicines, Gotenfia INN golimumab  Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of rheumatoid arthritis, juvenile…, Ranluspec INN ranibizumab Marketing authorisation applicant Lupin Europe GmbH Therapeutic indication Treatment of neovascular (wet) age-related macular…, Negative recommendation on new medicine, Blarcamesine Anavex INN blarcamesine  Marketing authorisation applicant Anavex Germany GmbH Therapeutic indication Treatment of Alzheimer’s disease and…, Positive recommendations on extensions of therapeutic indications , Arexvy Common name respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted) Market authorisation holder GlaxoSmithKline Biologicals More information…, Aspaveli INN pegcetacoplan  Marketing authorisation holder Swedish Orphan Biovitrum AB  More information Aspaveli: pending EC decision, Dovprela INN pretomanid  Marketing authorisation holder Mylan IRE Healthcare Limited More information Dovprela: pending EC decision, Elucirem INN gadopiclenol  Marketing authorisation holder Guerbet More information Elucirem: pending EC decision, Eylea INN aflibercept Marketing authorisation holder Bayer AG More information Eylea: pending EC decision, Mounjaro INN tirzepatide  Marketing authorisation holder Eli Lilly Nederland B.V More information Mounjaro: pending EC decision, Nucala INN mepolizumab  Marketing authorisation holder Glaxosmithkline Trading Services Limited More information Nucala: pending EC decision, Recarbrio INN imipenem / cilastatin / relebactam Marketing authorisation holder Merck Sharp & Dohme B.V.  More information Recarbrio: pending EC…, Simponi INN golimumab Marketing authorisation holder Janssen Cilag International More information Simponi: pending EC decision, Uplizna INN inebilizumab  Marketing authorisation holder Amgen Europe B.V More information Uplizna: pending EC decision, Vueway INN gadopiclenol Marketing authorisation holder Bracco Imaging S.p.A More information Vueway: pending EC decision, Winrevair INN sotatercept  Marketing authorisation holder Merck Sharp & Dohme B.V More information Winrevair: pending EC decision, Withdrawal of initial marketing authorisation application, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded Marketing authorisation applicant TETEC Tissue Engineering Technologies AG…, Negative recommendation on extension of therapeutic indications, Hetlioz INN tasimelteon Orphan designation This medicine was designated an orphan medicine. More information Hetlioz: pending EC decision, Article 29(4) referral Melatomed and associated names, Other updates, Vfend INN voriconazole Marketing authorisation holder Pfizer Europe MA EEIG More information Vfend: pending EC decision