EMA’s CHMP issued six positive opinions at its October 2026 meeting.
The recommendations covered:
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Rasonque (daraxonrasib) for previously treated metastatic pancreatic adenocarcinoma, following a phased review under EMA’s Cancer Medicines Pathfinder project.
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Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist for weight management and type 2 diabetes in adults.
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Yuviwel (navepegritide) for children with achondroplasia.
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Two biosimilars: Fovlussea (ranibizumab) and Neuzafy (filgrastim).
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Kizfizo (temozolomide), submitted through a hybrid application, for specified brain tumour indications.
CHMP also recommended indication extensions for Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza and Tukysa.
Following re-examination, the committee confirmed its recommendation to refuse marketing authorisation for Yartemlea (narsoplimab).
Applications to extend the uses of Ibrance and Truqap were withdrawn.
CHMP did not recommend the proposed paediatric AML use for Mylotarg, but agreed that study data should be included in product information.
It also recommended making Nyxoid available without prescription.
Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-october-2026
