Image credit: Corona Borealis Studio via Shutterstock
Gene therapies are transforming treatment for previously incurable diseases by replacing faulty genes rather than only treating symptoms. ARDAT explored how regulators worldwide assess their immunogenicity, identifying opportunities to harmonise guidance and support future regulation. ARDAT’s safety studies also generated evidence that helped families affected by a rare disease secure support for a clinical trial of a promising new gene therapy.
Read the full story here: IHI news