Posted by Michael Wonder on 25 Sep 2017
Kiadis Pharma receives FDA Regenerative Medicine Advanced Therapy designation for ATIR101
20 September 2017 - Kiadis Pharma today announces that the US FDA has granted ATIR101, Kiadis Pharma’s lead investigational product for blood cancers, the Regenerative Medicine Advanced Therapy designation.
FDA has already requested an additional meeting with Kiadis Pharma and will now work closely with the Company to provide guidance on the subsequent development of ATIR101 for improved overall survival and reduced transplant related mortality for patients receiving a haploidentical hematopoietic stem cell transplantation.
