Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

March 29, 2019 – EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions of indication at its first meeting in Amsterdam in March 2019. The Committee recommended granting a conditional marketing authorisation for Autologous CD34+ cells encoding βA-T87Q-globin gene, an advanced therapy medicinal product (ATMP) for beta-thalassaemia, a rare inherited blood condition … (leggi tutto)