News Releases
FDA Approves Rockwell's Triferic for Dialysis Patients
Rockwell Medical, Inc., announced today that the U.S. Food & Drug Administration (FDA) has approved its drug Triferic for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.
FDA Grants Orphan Drug Status to Soliris for Kidney Transplant Patients
The FDA has granted orphan drug designation to a medication to prevent failure of a transplanted kidney immediately after transplantation.
Affymax, Takeda Recall of All Lots of Omontys Injection
Affymax, Inc. and Takeda Pharmaceutical Company Limited today have decided to voluntarily recall all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life threatening or fatal.