Tag: pharmaceuticals
XORTX applies to EMA for orphan drug designation for PKD therapeutic
XORTX Therapeutics, a late-stage clinical pharmaceutical company focused on developing “innovative therapies to treat progressive kidney disease”, has announced in a press release that...
Statistical modelling promises better identification of drug-induced AKI
Drug-induced acute kidney injury (DI-AKI) is “challenging to distinguish” from other types of AKI even for “experienced nephrologists”, yet this adverse drug event (ADE)...
Positive budesonide trial results earn FDA drug application approval
Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted a submission for a supplemental New Drug Application (sNDA) for...
Phase 1 study of kidney transplant rejection drug initiated
Tonix Pharmaceuticals has announced the initiation of a Phase 1 single ascending dose escalation study of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody or mAb),...
Empagliflozin approved in the EU for CKD
The European Commission (EC) has approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company has...
ASPEN trial finds roxadustat effective for treating anaemia in large dialysis...
New research has been published in Hemodialysis International which, say its authors, “enhances understanding” of how haemodialysis centres can utilise oral roxadustat. The anaemia...
Remdesivir supplemental drug application for CKD patients approved by FDA
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of...
ProKidney announces new vice president of clinical development
ProKidney, a late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), has announced the appointment of Bruce Culleton as executive vice president...