Niagen Bioscience Inc.’s proprietary lead small-molecule drug candidate, NB-4168, has been awarded European orphan drug designation and U.S. rare pediatric disease designation for the treatment of ataxia telangiectasia.
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.”
The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs.
