Posted by Michael Wonder on 14 Nov 2023
FDA grants fast track designation to SonALAsense’s Sonala-001 in combination with the Insightec transcranial ultrasound device for sonodynamic therapy of DIPG, a rare paediatric brain cancer
14 November 2023 - SonALAsense today announced that the US FDA has granted fast track designation to the development program of Sonala-001 in combination with the Insightec Exablate 4000 Type 2 device for the treatment of patients with diffuse intrinsic pontine glioma.
This builds upon Sonala-001 also having received orphan drug designation in 2021 for malignant gliomas.
