FDA News

Announced on April 6, the recall, which is the most serious of its kind, includes all Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems distributed from November 2017-February 2023, which totals more than 4 million devices in the US.

The FDA’s move to withdraw hydroxyprogesterone caproate injection (Makena) was a joint decision by both the FDA’s Commissioner and its Chief Scientist.

Data suggest confirmatory trials conducted for drugs granted accelerated approval by the FDA have taken a median 3.5 years to complete since 2012.

This 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.

There is a June 22 PDUFA date for obeticholic acid, which if approved would become the first FDA-approved treatment for NASH.

The 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.

Announced 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.

Announced 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.

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.