BrainChild Bio Inc. announced that its investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation by FDA for the treatment of diffuse intrinsic pontine glioma, an incurable pediatric brain tumor.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
