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Top Stories of July 2021:
- FDA Approves Semglee, Its First Interchangeable Biosimilar Insulin Product
Announced on July 28, insulin glargine-yfgn (Semglee) becomes the first interchange biosimilar insulin product to receive approval in the FDA's history and is expected to be available by the end of the year.
- Finerenone (KERENDIA) Approved for Chronic Kidney Disease Associated with Type 2 Diabetes
With approval on July 9, finerenone (Kerendia) becomes the first nonsteroidal mineralocorticoid receptor antagonist to receive approval for use in adults with chronic kidney disease associated with type 2 diabetes.
- Exenatide Extended-Release Receives Historic FDA Approval for Use in Pediatric Type 2 Diabetes
With approval, exenatide extended-release (BYDUREON BCise) becomes the first weekly GLP-1 RA therapy to receive approval for improving glycemic control in pediatric patients aged 10-17 years with type 2 diabetes.
- FDA Approves Spinal Cord Stimulation Therapy for Painful Diabetic Neuropathy
With approval announced on July 19, HFX becomes the only spinal cord stimulation therapy approved by the FDA with a specific indication for painful diabetic neuropathy.
- National Kidney Foundation Provides Updated Guidelines for Kidney Transplants
The National Kidney Foundation released a position statement on July 27 providing new guidance related to kidney transplants in the US.