Donrafylix
Stories
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EMA recommends approval of seven new medicines at CHMP meeting
The Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Aumseqa, Baxfendy, Zybrivo, Garzulys, Donrafylix, Fondaparinux sodium Evumed, and Ruxolitinib Krka. The recommendations cover treatments for non-small cell lung cancer, hypertension, non-squamous non-small cell lung cancer, diabetes, venous thromboembolism, and myelofibrosis, among others.
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CHMP adopts positive opinion on Donrafylix
On 12 November 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Donrafylix, a biosimilar insulin aspart intended for the treatment of diabetes mellitus. The applicant is Kuraci BV and Donrafylix will be available as a 100 units/ml solution for injection.