FDA approves first radioligand generic, pitting Curium against Novartis' Lutathera

The U.S. Food and Drug Administration has granted approval to Curium’s radioligand product, the first generic in this therapeutic class.

The approved drug is a direct equivalent of Novartis’ Lutathera, a leading radioligand therapy used for certain cancers.

The decision introduces direct competition for Novartis, which could influence market pricing and patient access.