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EMA’s CHMP adopts five orphans

Five of six positive opinions by the committee are for new orphan drugs, but also two of three negatives

July 25, 2025 8:40 PM UTC

CHMP’s July meeting recommended five new orphan drugs for approval, but did not back approval of two others.

In total, there were six positive opinions for new products and three negative opinions, with three more MAAs withdrawn during review. Two of the withdrawn candidates also had orphan designation...