FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis

The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies.

The therapy was designed to deliver radioactive isotopes directly to tumor cells, an emerging approach that could have competed with Novartis' products.

The decision pauses the drug's development and highlights the regulatory focus on manufacturing quality in the radiopharma field.