September 5th 2024
The FDA has granted full approval to sparsentan (Filspari) for slowing kidney function decline in adults with IgAN at risk of disease progression based on PROTECT trial data.
10 Years of SGLT2 Inhibitors: A Decade of Redefining Cardiometabolic Care
March 29th 2023This feature articles commemorates the 10-year anniversary of the FDA's first approval of an SGLT2 inhibitor on March 29, 2013 and provides a snapshot at the class's ascent into the treatment algorithms and guidelines for type 2 diabetes, heart failure, and chronic kidney disease.
FDA Approves Narcan Nasal Spray for Over-the-Counter Use
March 29th 2023The approval, which is for 4 mg naloxone hydrochloride nasal spray, marks the first OTC, nonprescription approval for a naloxone nasal spray and allows the product to be sold directly to consumers in a variety of retail locations well as online.
Omnipod 5 Receives Clearance for Use in Ages 2 and Older with Type 1 Diabetes
August 22nd 2022Announced on Aug. 22, the US FDA's clearance of the Omnipod 5 AID system in type 1 diabetes for patients aged 2 years and older comes less than 7 months after receiving clearance in patients aged 6 years and older.
Tirzepatide (Mounjaro) Wins FDA Approval for Type 2 Diabetes
May 13th 2022Announced on May 13, the approval indicates Eli Lilly and Company's novel dual GLP-1/GIP agonist, tirzepatide (Mounjaro), for use as an adjunct to diet and exercise to improve blood sugar in adult patients with type 2 diabetes.
Finerenone (KERENDIA) Approved for Chronic Kidney Disease Associated with Type 2 Diabetes
July 9th 2021With 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.