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 NASHMay 20th 2023
The 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 Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye DiseaseMay 19th 2023
Announced by Bausch + Lomb and Novaliq, the prescription eye drop for DED is the first and only drop that directly targets tear evaporation, with approval based on results from 2 pivotal phase 3 trials.
FDA Approves First Hyaluronic Acid Microdroplet Injection for Lasting 6 Months without Recurring TreatmentsMay 15th 2023
The Food and Drug Administration approved the intradermal microdroplet injection, a hydrating gel product designed to smooth out patients’ skin in those over 21 of all Fitzpatrick skin types.
FDA Committee Votes in Favor of Intranasal Epinephrine for Severe Allergic Reactions Including AnaphylaxisMay 12th 2023
It was announced by ARS Pharmaceuticals, Inc., that a US Food and Drug Administration Drug Advisory Committee voted in favor of a new intranasal epinephrine treatment for severe allergic reactions.
FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart FailureMay 9th 2023
Announced 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.
FDA Issues Complete Response Letter for TransCon PTH in HypoparathyroidismMay 1st 2023
Announced on May 1, the CRL from the FDA expressed concerns related to manufacturing control strategy, but did not express concern related to clinical data submitted as part of the NDA package for TransCon PTH.
Tirzepatide Achieves Mean Weight Loss of 15.7% in SURMOUNT-2 TrialApril 27th 2023
Data 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 DiabetesApril 25th 2023
Announced 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 Approves Medtronic's MiniMed 780G System for People with Type 1 DiabetesApril 22nd 2023
On April 21, 2023, Medtronic announced the long-awaited US approval of their MiniMed 780G System with Smart Guard Technology and the Guardian 4 Sensor, which has been available in Europe for nearly 3 years.
FDA Issues Class I Recall of Abbott FreeStyle Readers for Risk of Overheating, FireApril 6th 2023
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.
10 Years of SGLT2 Inhibitors: A Decade of Redefining Cardiometabolic CareMarch 29th 2023
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.