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Tag: anaemia


FDA, Regulations

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

October 28, 2022

Via: PMLiVE

The advisory committee experts, however, voted 11 to five against the use of daprodustat in non-dialysis patients with anaemia of CKD, citing increased safety risks such as heart failure and bleeding gastric erosions. The FDA will consider the vote, feedback […]


FDA, Regulations

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

July 15, 2021

Via: PMLiVE

AZ and FibroGen are aiming for approval of roxadustat for the treatment of anaemia caused by chronic kidney disease (CKD). In briefing documents published ahead of a meeting of the Cardiovacular and Renal Drugs Advisory Committee meeting on 15 July, […]