Category: North America

June 19, 2019 Off

CARsgen Therapeutics’ leading candidate gets FDA IND clearance

By Dino Mustafić

One of CARsgen Therapeutics’ leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).

June 19, 2019 Off

ObsEva clears issues with FDA over nolasiban

By Dino Mustafić

ObsEva’s has recently cleared with the U.S. Food and Drug Administration (FDA) several important development issues for its oral oxytocin receptor antagonist nolasiban, which enables it to begin its U.S. Phase 3 clinical trial (IMPLANT 3) in the fourth quarter of this year or early 2020.