Kazia Therapeutics, an Australian oncology company, has secured fast track designation (FTD) from the US Food and Drug Administration (FDA) for paxalisib (formerly GDC-0084) for the treatment of glioblastoma. The specific indication for which the designation has been granted is for newly diagnosed glioblastoma patients with unmethylated O6-Methylguaninemethyltransferase (MGMT) promotor status who had initial radiation […]
Kazia Therapeutics, an Australian biotech company, has secured the rare pediatric disease designation (RPDD) for paxalisib (formerly GDC-0084) from the US Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG). Diffuse intrinsic pontine glioma is considered to be a rare and highly-aggressive childhood brain cancer. The rare pediatric disease designation […]
