Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
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Six new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.
Rasonque (daraxonrasib) received a positive opinion from the CHMP for the treatment of adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment. This recommendation follows a phased review of data on Rasonque, which was identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder project, given its potential to address this unmet medical need. See more details in the news announcement in the grid below.
The committee recommended granting a marketing authorisation for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults. Foundayo will be available as a tablet taken once daily, providing an alternative to injectable and other oral GLP-1 receptor agonists. See more details in the news announcement in the grid below.
The CHMP recommended granting a marketing authorisation for Yuviwel (navepegritide), for the treatment of achondroplasia in children. Achondroplasia is an inherited disease caused by a mutation in a gene called fibroblast growth-factor receptor 3. The mutation affects growth of almost all bones in the body including the skull, spine, arms and legs, resulting in very short stature with a characteristic appearance.
The committee adopted positive opinions for two biosimilar medicines:
This is an extract. The publication continues at the source.
Source: European Medicines Agency.
Read the original at the source: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-october-2026
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- October 16, 2026 11:00
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https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human...