FDA News

Announced by the US FDA on May 19, 2023, the clearance of the iLet ACE Pump and the iLet Dosing Decision Software, when combined with a compatible CGM, will form the iLet Bionic Pancreas.

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.

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.

The FDA approval comes with supporting data showing the ERT's non-inferiority to agalsidase beta in controlled eGFR decline.

Announced on May 10, 2023, topline results of the phase 2 dose-finding trial for BI 456906 suggests use was associated with reductions in body weight of up to 14.9% during the 46-week study.

Pending FDA approval, RVO would be the third indication for faricimab-svoa in addition to wet age-related macular degeneration and diabetic macular edema.

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.

The announcement resulted from the FDA’s request for manufacturing, administration, and patient monitoring information.

Older adults with comorbidities, including diabetes and chronic heart and lung disease, are at an increased risk of RSV hospitalization and death.

The extended-release injectable suspension treatment represents the first subcutaneous, long-acting formulation of risperidone.

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.

The long-acting injectable can be administered once every 2 months to either treat schizophrenia or serve as a maintenance monotherapy for bipolar disorder.

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.

The treatment is the second live microbiota therapeutic approved by the FDA, coming just a few months after the agency approved RBX2660 for recurrent C. difficile infections.

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.

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.

It was announced by Arcutis Biotherapeutics that the US Food and Drug Administration had accepted for review their NDA for roflumilast foam 0.3%.

Announced on April 14, the clearance allows for FreeStyle Libre 3 users to obtain real-time glucose readings on a large, easy-to-see screen directly from their back of arm sensors.

According to Horizon Therapeutics, the updated indication language reinforces the importance of access for patients across the full spectrum of TED activity or duration.

From a novel topical gene therapy to a multi-pathway targeting HF drug, the second quarter of 2023 is laden with interesting regulatory decisions.

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.