Q2 2025 Recap: Endocrinology News and Updates

The second quarter of 2025 brought meaningful developments in endocrinology, from FDA actions to clinical breakthroughs spotlighted at major meetings. Several regulatory milestones signaled progress for patients across the spectrum of endocrine disorders, including expanded access to CGM technology, new formulations for adrenal insufficiency, and a broader treatment label for Cushing’s syndrome.

Novo Nordisk’s NDA for 25 mg oral semaglutide also marked a potential turning point in obesity care, with the first oral GLP-1 formulation for weight management now under review. Meanwhile, June’s ADA Scientific Sessions capped the quarter with a surge of new data on incretin therapies, obesity drugs, and diabetes technology—many with practice-changing potential.

Here’s a look back at the most impactful regulatory updates and conference highlights shaping the future of endocrine care.

Regulatory Updates in Endocrinology

FDA Clears Dexcom G7 15-Day CGM System

On April 10, 2025, the FDA cleared Dexcom’s G7 15-day continuous glucose monitoring (CGM) system for adults with diabetes, making it the longest-lasting and most accurate CGM approved in the U.S. Based on clinical data showing a MARD of 8.0%, the G7 15 Day demonstrated excellent accuracy and user satisfaction. According to Dexcom, the system offers features like Apple Watch integration, waterproof sensors, and extended wear with a 12-hour grace period for sensor changes. The company plans to ensure compatibility with insulin pump systems ahead of its US launch in late 2025.

FDA Approves Label Expansion for Osilodrostat for Cushing's Syndrome

On April 16, 2025, the FDA approved Recordati’s sNDA for osilodrostat (Isturisa), expanding its indication to include adults with endogenous Cushing’s syndrome who are not surgical candidates or for whom surgery was not curative. Previously approved only for Cushing’s disease, the broader label is supported by data from the LINC 3 and LINC 4 trials showing sustained cortisol reduction and clinical improvement. According to Recordati, osilodrostat offers a vital option for managing hypercortisolemia and preventing severe complications.

FDA Accepts NDA Submission for Oral Semaglutide 25 mg

On May 2, 2025, Novo Nordisk announced the FDA accepted its NDA for a once-daily 25 mg oral formulation of semaglutide for chronic weight management in adults with obesity or overweight and at least one comorbidity. Based on results from the 64-week OASIS 4 trial, the oral semaglutide demonstrated significant weight loss and cardiovascular risk reduction. According to Novo Nordisk, this could become the first oral GLP-1 therapy approved for obesity. If approved, it would expand individualized treatment options beyond injectable formulations. An FDA decision is expected in Q4 2025.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

On May 28, 2025, the FDA approved Eton Pharmaceuticals’ hydrocortisone oral solution (KHINDIVI) for pediatric patients aged 5 and older with adrenocortical insufficiency, marking the first liquid formulation approved for this use. Designed for accurate, individualized dosing, the 1 mg/mL solution helps patients who have difficulty swallowing pills. According to Eton, this ready-to-use formulation eliminates the need for pill-splitting and supports improved treatment outcomes during childhood development.

American Diabetes Association

June 2025 also brought several groundbreaking trials and new updates in diabetes care at the 8th American Diabetes Association Scientific Sessions, which were held in Chicago, Illinois from June 20-23, 2025. With multiple sessions dedicated to late-breaking research, the meeting featured multiple simultaneous publications, including a slew of studies related to incretin therapies. To learn more about the meeting’s top news, check out this trio of articles recapping ADA 2025.

• ADA 2025 Recap: 7 Trials to Know
• ADA 2025 Recap: 5 Studies on Obesity to Know
• HCPLive Five at ADA Scientific Sessions 2025

Diabetes Dialogue

Diabetes Dialogue: Semaglutide for MASH in ESSENCE Trial, With Arun Sanyal, MD

In this episode, the hosts discuss new Phase 3 data from the ESSENCE trial showing that once-weekly semaglutide 2.4 mg significantly improved liver outcomes and reduced weight in patients with MASH and stage 2 or 3 fibrosis. They speak with the trial’s lead author about semaglutide’s clinical impact, its potential as a future MASH treatment, and how it compares to the currently approved option, resmetirom.

Diabetes Dialogue: AACE 2025 Recap

In this episode, the hosts recap key moments from the 2025 AACE Annual Meeting, covering major plenaries, hands-on tech workshops, and the launch of a new diabetes technology certification program. They spotlight updates on GLP-1 safety, health equity, CGM innovations, and emerging trial data, while reflecting on the future of personalized diabetes care.

Diabetes Dialogue: Real-World Impact of iLet Bionic Pancreas, With Steven Russell, MD, PhD

In this episode, the hosts speak with the Chief Medical Officer of Beta Bionics about real-world outcomes from the iLet Bionic Pancreas, an FDA-cleared fully autonomous insulin delivery system requiring no user settings. They highlight its strong A1c-lowering effect, minimal hypoglycemia, and promise for underserved populations and primary care use, including off-label applications in type 2 diabetes.

Diabetes Dialogue: REDEFINE 1 and REDEFINE 2, with Timothy Garvey, MD, and Melanie Davies, MD

In this episode recorded at ADA 2025, the hosts break down results from the REDEFINE 1 and 2 trials showing that CagriSema delivered substantial weight loss and glycemic improvements in people with and without type 2 diabetes. They also discuss the drug’s safety, clinical relevance, and future in obesity care with trial investigators, highlighting upcoming studies like REDEFINE 3.