Endocrinology

The FDA's decision to issue a CRL was announced on October 08, 2024 and cites issues with the timing of the facility inspection.

Time-restricted eating, even without calorie restriction, improved glycemic control and cardiometabolic health in patients with metabolic syndrome.

Our September 2024 monthly recap in endocrinology spotlights regulatory updates, new guidelines, and the latest episodes of Diabetes Dialogue.

A review of 5 highly anticipated FDA decisions expected by year-end, including acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for T1D and CKD, and more.

Ascendis Pharma has submitted a sBLA to the FDA for TransCon hGH for the treatment of adults with growth hormone deficiency.

Lack of retinopathy, lower hemoglobin A1c levels, preserved eGFR, microalbuminuria, and lower UPCR were linked to non-DKD.

There were no differences in the treatment effect of ertugliflozin on gout-related outcomes in subgroups based on eric acid quintile or other baseline characteristics.

The FDA has approved the Eversense 365, the world’s first 1-year continuous glucose monitor, with US availability expected in late 2024.

A new study found glucagon-like peptide 1 receptor agonist use was associated with a lower risk of cirrhosis complications for patients with MASLD who did not have cirrhosis.

The endocrinology month in review for August 2024 spotlights 6 pieces of major pipeline news or regulatory announcements as well as multiple episodes of Diabetes Dialogue.

Semaglutide lowers rates of cardiovascular and COVID-19-related deaths in patients with overweight/obesity, offering promising cardio-metabolic and non-cardiovascular benefits.

Michigan Medicine and U-M research finds a bidirectional link between mental health disorders and chronic diabetes complications, urging comprehensive screenings.

FDA expands Omnipod 5 AID system for type 2 diabetes, marking the first AID system approved for both type 1 and type 2 diabetes management.

Dexcom's Stelo, the first OTC glucose sensor, launches in the US on August 26, 2024, offering 15-day wear and HSA/FSA eligibility for as low as $89.99 per 2-pack.

A new study significantly demonstrated semaglutide, but not liraglutide, is associated with suicidal ideation.

A new analysis suggests HbA1c may be more informative to fatty liver disease severity than BMI, and should be included in screenings.

A new real-world study suggests tirzepatide provides greater reductions in mortality, cardiovascular risk, and kidney events than GLP-1 receptor agonists in type 2 diabetes.

Palopegteriparatide’s approval was based on positive data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials.

In this episode, hosts take a break from the ADCES meeting to discuss the latest news from Medtronic related to their Simplera CGM and their partnership with Abbott.

FDA approval for the Simplera™ continuous glucose monitor marks the company's first disposable, all-in-one CGM half the size of previous offerings.

The July 2024 endocrinology month in review recaps a pair of regulatory updates, multiple studies on incretin therapies, and the most recent episodes of our flagship diabetes podcast, Diabetes Dialogue.

An analysis of more than 11,000 people with T1D found people were more likely to report an affected father than an affected mother.

New study finds semaglutide may reduce smoking urge in type 2 diabetes patients, decreasing tobacco use disorder medical encounters by up to 32%.

An analysis using records from 40 million US patients highlights the surge in new GLP-1 receptor agonist use, with semaglutide dominating new prescriptions since 2020.

Findings highlight an increased risk of diabetes, MASLD, and cardiovascular disease in patients with PCOS, with risk varying by PCOS phenotype.

In this episode, John Buse, MD, PhD, discusses the background, expected prevalence, reaction to results, and the importance of the second part of the CATALYST trial.

The CRL cites requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.

Findings from a meta-analysis examining 12 trials including more than 70,000 patients with diabetes support combining SGLT2 inhibitors and GLP-1 RAs.

A study of 18,000 patients showed tirzepatide (Mounjaro) led to more significant weight loss than semaglutide (Ozempic) in adults with overweight or obesity.

In the endocrinology month in review, we spotlight top news in the endocrinology pipeline and the most important updates from ADA 2024.