Fuente: EMA. News 12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its February 2026 meeting.The committee recommended…, CHMP statistics Key figures from the February 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, mCombriax Common name Influenza and COVID 19, mRNA vaccine Marketing authorisation applicant Moderna Biotech Spain S.L. Therapeutic indication Immunisation…, Ojemda INN tovorafenib  Marketing authorisation applicant Ipsen Pharma  Therapeutic indication Treatment of paediatric low-grade glioma (LGG).…, Onerji INN levodopa / carbidopa  Marketing authorisation applicant Tanabe Pharma GmbH Therapeutic indication Treatment of motor fluctuations in patients…, Palsonify INN paltusotine Marketing authorisation applicant Crinetics Pharmaceuticals Europe GmbH Therapeutic indication Medical treatment of adult patients…, Rhapsido INN remibrutinib Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of chronic spontaneous urticaria (CSU…, Xolremdi INN mavorixafor Marketing authorisation applicant X4 Pharmaceuticals (Austria) GmbH Therapeutic indication Treatment of WHIM syndrome. More…, Positive recommendations on new biosimilar medicines, Bysumlog INN insulin lispro  Marketing authorisation holder Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Dazparda INN insulin aspart  Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH Therapeutic indication Treatment of diabetes…, Fubelv INN etanercept  Marketing authorisation holder Biosimilar Collaborations Ireland Limited Therapeutic indication Treatment of rheumatoid arthritis…, Poherdy INN pertuzumab Marketing authorisation holder Organon N.V. Therapeutic indication Treatment of breast cancer in adults.  More information…, Tuyory INN tocilizumab  Marketing authorisation holder Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) Therapeutic indication Treatment of…, Zandoriah INN teriparatide  Marketing authorisation holder Cinnagen Co Unipessoal Lda. Therapeutic indication Treatment of osteoporosis. More…, Positive opinions for medicines intended for use outside EU, Acoziborole Winthrop International non-proprietary name (INN) acoziborole  Marketing authorisation applicant Sanofi Winthrop Industrie  Therapeutic…, Negative recommendation on new medicines, Daybu INN trofinetide Marketing authorisation holder Acadia Pharmaceuticals (Netherlands) B.V. Orphan designation This medicine was designated an orphan…, Iloperidone Vanda Pharmaceuticals INN iloperidone  Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Iloperidone…, Positive recommendations on extensions of therapeutic indications , Dupixent INN dupilumab  Marketing authorisation holder Sanofi Winthrop Industrie More information Dupixent : pending EC decision, Jorveza INN budesonide  Market authorisation holder Dr. Falk Pharma GmbH More information Jorveza : pending EC decision, Keytruda INN pembrolizumab Market authorisation holder Merck Sharp & Dohme B.V. More information Keytruda : pending EC decision, Olumiant INN baricitinib Market authorisation holder Eli Lilly Nederland B.V. More information Olumiant : pending EC decision, Scemblix INN asciminib Market authorisation holder Novartis Europharm Limited More information Scemblix : pending EC decision, Stelara INN ustekinumab Market authorisation holder Janssen-Cilag International NV More information Stelara : pending EC decision, Withdrawals of initial marketing authorisation application, Zumrad INN sasanlimab  Marketing authorisation applicant Pfizer Europe MA EEIG More information Zumrad : pending EC decision, Other updates Scientific advice and protocol assistance adopted during the CHMP…