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Stay up-to-date with the latest in FDA decisions, trial readouts, and key clinician insights from all corners of endocrinology.
Endocrinology saw some significant advancements over the last 30 days, with key approvals from the US Food and Drug Administration (FDA) widening access to key treatments in a range of conditions. From new insulin delivery systems in type 1 diabetes (T1D) to a new weekly basal insulin for type 2 diabetes (T2D), the FDA covered quite a bit of ground in September.
Additionally, we saw the beginning of the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting, which brought with it a long list of key trial readouts and clinician insights to the fore.
With so many headlines released in the last month, the HCPLive team has collected 8 of the most impactful news below. Catch up on some of the key readouts and approvals that you may have missed:
On September 14, 2026, the FDA cleared the Mint insulin patch pump from Beta Bionics, a 2-piece reusable and disposable system designed to be smaller than the leading Omnipod 5. Each patch is designed for 3 days of wear with a 12-hour grace period and contains a 200-unit insulin reservoir. Additionally, the pump will receive firmware updates over the air, avoiding the issue of phone re-pairing. Mint is expected to be commercially available in the first quarter of 2027.
Finerenone saw a label expansion approved by the FDA on September 17, 2026, marking the first new treatment option for chronic kidney disease (CKD) associated with T1D in >30 years. According to the announcement from Bayer, the approval was granted through the priority review system and was based on data from the FINE-ONE trial. This program saw finerenone outperform placebo in reducing the urine albumin-to-creatinine ratio over 6 months.
On September 24, 2026, the FDA announced its approval of insulin efsitora alfa-gobe, a once-weekly basal insulin, to improve glycemic control in T2D. The decision, based on the phase 3 QWINT program of 4 separate trials, adds Eli Lilly’s new insulin to the exclusive once-weekly group, of which insulin icodec is the only other member. The studies support this injectable’s capacity to reduce basal injections from 365 to roughly 52 per year compared to once-daily basal insulin.
An investigational combination of eloralintide and tirzepatide, dubbed EloraTZP, significantly outperformed tirzepatide alone in patients with obesity or overweight and T2D. In a phase 2b trial presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting, EloraTZP led to substantially greater body weight and A1c reductions at 48 weeks, with all EloraTZP dose combinations meeting all primary and secondary endpoints.
The TRIUMPH-1 study has demonstrated retatrutide’s substantial efficacy in reducing weight in obesity, improving pain in knee osteoarthritis, and reducing apnea-hypopnea events in obstructive sleep apnea. The GLP-1/GIP/glucagon triple agonist demonstrated its overwhelming efficacy, with body weight loss of roughly 25% at the highest dose compared with placebo. Additionally, retatrutide’s safety data was consistent with prior phase 2 trials, with the most common adverse events mild to moderate in severity.
Semaglutide dose escalation has demonstrated a clinically significant reduction in major adverse cardiovascular event (MACE) risk compared to switching to tirzepatide, according to the real-world COMPETE SWITCH CV trial from Novo Nordisk. Presented at EASD 2026, the analysis aimed to address a common decision point in clinical practice: whether or not to intensify GLP-1 therapy with a higher semaglutide dose or tirzepatide. Although safety outcomes were not assessed in the analysis, Novo Nordisk has stated the potential for this trial to inform healthcare professionals facing this frequent challenge.
In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA’s approval of weekly insulin efsitora alfa. The duo expressed excitement for the new option, while also noting the potential barriers of education regarding loading doses, concentrated pen conversions, and coverage, as insulin icodec saw similar gaps following its launch earlier in 2026.
In this episode of Diabetes Dialogue, Isaacs and Bellini discuss finerenone’s FDA approval for CKD in T1D. In addition to highlighting its promising potential in this patient population, the cohosts also noted its inherent hyperkalemia risk, acknowledging that it should not be combined with steroidal mineralocorticoid receptor antagonists or concurrent ACE inhibitor therapy. They also addressed their own challenges in screening for the urine albumin-to-creatinine ratio, advising clinicians as to methods to obtain these readings.