The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.

Abbott Laboratories received CE mark in Europe for the Tactiflex Duo ablation catheter to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device, were completed in the EU this week.

The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.