FDA blocks ITM's radiotherapy drug over manufacturing defects, clinical data intact

The US FDA issued a Complete Response Letter to Germany-based ITM Isotope Technologies Munich SE blocking approval of its radiotherapeutic ITM-11 due to manufacturing and facility compliance issues, with clinical and safety data remaining unaffected. Resolution of the manufacturing deficiencies at a third-party facility is required before NDA approval can proceed.

This Wire brief sits within Fusion42's coverage of Biotech.