Transplants Archives - Page 4 of 4

Orchard Therapeutics Receives EMA PRIME Designation for OTL-300

European Medicines Agency (EMA), Gene Therapy, Hematopoietic Stem Cell Transplantation (HSCT), Metachromatic Leukodystrophy (MLD), Priority Medicines (PRIME) Designation, Rare Diseases, Transfusion-Dependent Beta-Thalassemia (TDT), Wiskott–Aldrich Syndrome (WAS), X-Linked Chronic Granulomatous Disease (X-CGD)

Orchard Therapeutics announced that the European Medicines Agency granted Priority Medicines (PRIME) designation to OTL-300, an investigational autologous ex vivo lentiviral gene therapy for the treatment of transfusion-dependent beta-thalassemia.

October 4, 2018/by GlobeNewswire

U.S. FDA Grants Priority Review for Daratumumab

FDA/Regulatory, Multiple Myeloma, Priority Review, Stem Cell Transplant, Supplemental New Drug Application (sNDA)

The U.S. FDA granted Priority Review to daratumumab as a combination treatment for patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant.

January 19, 2018/by Administrator