At its February 2026 meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval, marking a significant advancement in therapeutic options. Among the highlights are mCombriax, an mRNA vaccine for influenza and COVID-19 developed by Moderna Biotech, and Ojemda, a treatment for pediatric low-grade glioma from Ipsen Pharma. Other notable recommendations include Onerji for motor fluctuations in Parkinson’s patients and Rhapsido for chronic spontaneous urticaria, showcasing a diverse therapeutic landscape.
The CHMP’s recommendations also extended to several biosimilars, including Bysumlog and Dazparda, both aimed at diabetes management. These approvals underscore the growing emphasis on biosimilar products in the EU market, which can enhance patient access to essential therapies. Furthermore, positive opinions were issued for medicines intended for use outside the EU, reflecting the committee’s broader regulatory strategy.
However, the meeting was not without its setbacks, as the CHMP issued a negative recommendation for Daybu, a treatment for orphan diseases, indicating ongoing challenges in the regulatory landscape. Overall, the February 2026 meeting highlights the CHMP’s commitment to advancing innovative therapies while navigating the complexities of drug approval.
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