June 1st 2023
The approval for Abrysvo represents the second RSV vaccine approved for adults aged 60 years and older in the last month.
FDA Committee Votes Against Risk-Benefit Profile of OCA 25 mg for NASH
May 20th 2023The June 22, 2023 PDUFA date for obeticholic acid 25 mg oral tablets for the treatment of precirrhotic liver fibrosis appears to be in jeopardy after a May 23, 2023 meeting of the FDA's Gastrointestinal Drugs Advisory Committee.
FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart Failure
May 9th 2023Announced just more than a year after AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular death and HF hospitalizations for dapagliflozin based on results of the phase 3 DELIVER trial.
Tirzepatide Achieves Mean Weight Loss of 15.7% in SURMOUNT-2 Trial
April 27th 2023Data from the SURMOUNT-2 trial demonstrate use of tirzepatide 10 mg and 15 mg were associated with mean weight reductions of 13.4% and 15.7%, respectively, with more than 80% of tirzepatide users achieving a body weight reduction of 5% or greater.
Omnipod GO Receives FDA Clearance for People with Type 2 Diabetes
April 25th 2023Announced on April 25, 2023, the FDA's clearance of the Omnipod GO marks the first-of-its-kind for a basal-only insulin pod and is indicated for use as an insulin delivery device for people with type 2 diabetes aged 18 or older.
FDA Issues Class I Recall of Abbott FreeStyle Readers for Risk of Overheating, Fire
April 6th 2023Announced 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.
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.