Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file.
The EMA is recommending withdrawing Amgen Inc.’s complement inhibitor Tavneos (avacopan) from the market in Europe, saying data provided at the time it assessed the MAA “were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.”
Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.