CHMP February 2026: 12 medicines move toward EU approval, including a first combined flu-COVID vaccine
CHMP’s February 2026 meeting recommended 12 medicines for EU approval (including mCombriax, the first combined influenza and COVID-19 mRNA vaccine) and granted a conditional authorisation for Ojemda to treat paediatric low-grade glioma. Positive opinions were issued for Onerji (Parkinson’s), Palsonify (acromegaly), and Rhapsido (chronic spontaneous urticaria), plus six biosimilars. Acoziborole Winthrop received a positive outside-EU opinion. Negative opinions were given for Daybu and Iloperidone. Extensions of indication were recommended for Dupixent, Jorveza, Keytruda, Olumiant, Scemblix, and Stelara, with Zumrad withdrawn. Minutes will follow, and many decisions await EC approval.
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026 European Medicines Agency
- Moderna’s 2-in-1 flu and COVID vaccine shows encouraging results in small trial CIDRAP
- Moderna Gets EU Approval for mRNA Combination Covid-Flu Shot Bloomberg
- European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19 Yahoo Finance
- Moderna’s Covid-Flu Vaccine Recommended for Approval in EU WSJ
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