Tag: Investigational New Drug (IND)

July 19, 2017 Off

FDA accepts new IND to expand in U.S. IFNalpha kinoid clinical development program in dermatomyositis

The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.

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.