Category: news

March 9, 2017 Off

Servier cleared for UCART development in the USA

By Dino Mustafić

Servier has been cleared with Investiga New Drug (IND) by the U.S. Food and Drug Administration (FDA) for the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.

March 8, 2017 Off

FDA accepts Allergan’s sNDA for schizophrenia treatment

By Dino Mustafić

U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating VRAYLAR for the maintenance of efficacy in adults with schizophrenia to the current product label.