Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data.
The miss is the latest setback for the company whose application seeking approval for the drug to treat anemia in kidney disease patients was rejected by the U.S. Food and Drug Administration in 2021 seeking additional data.
Fresenius Medical Care shares hit their highest level in nearly seven months on Wednesday, welcoming news that FMC parent Fresenius would cede control over the struggling dialysis firm but keep its stake for now as part of a turnaround plan.
The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc’s drug as the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.
Baxter International Inc. said on Friday it plans to spin off its kidney care units, becoming the latest medical device maker to slim down in the face of supply-chain challenges.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).