FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
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.
