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OfficialEMA newsOct 16, 2026

EMA reports that its CHMP recommended approval of six medicines and broader uses for five authorised medicines at its October 2026 meeting. It also agreed to include study data on Mylotarg in children with newly diagnosed acute myeloid leukaemia in the product information, while not recommending that use.

Why it matters: EMA says adding the Mylotarg study data to product information will give healthcare professionals access to current findings in these children.

Approvals and labelsAI summary
Read at EMA

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