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A look at 13 key FDA approvals from Q1 2026, highlighting advances in rare disease, pediatrics, novel therapies, and patient-centered innovation.

Amgen has announced positive topline results from their phase 3 trial comparing teprotumumab-trbw – administered via an on-body injector – to placebo.

This episode covers the March 26th approval of Awiqli for T2D, highlighting its high concentration and once-weekly administration.

This episode discusses the recently released algorithm for T2D from the American Association of Clinical Endocrinology.

Indirect data suggest oral semaglutide may reduce weight more than orforglipron, but cross-trial comparisons limit clinical interpretation.

This episode addresses the groundbreaking approval of the first GLP-1 RA without timing or meal restrictions.

Laurel Messer, PhD, RN, joins the show to provide insight into the latest updates from Tandem Diabetes Care.

REMODEL reveals how semaglutide protects kidneys, showing reduced inflammation, improved vascular health, and evidence of structural repair in diabetic CKD.

The indication makes insulin icodec the first new class of basal insulin to reach US patients in more than 2 decades.

Fahed explains how a multi-ancestry metabolic poly genetic risk score from over 8.5 million individuals points to the utility of global collaboration in genetic research.

Witkowski discusses the data presented at ATTD 2026, highlighting the investigative anti-CD40L monoclonal antibody in facilitating insulin independence.

National cohort study finds semaglutide tied to reduced depression, anxiety, and self-harm risk in patients with diabetes and comorbid mental illness.

A metabolic polygenic risk score built from 20 traits and more than 8.5 million individuals outperformed existing disease-prediction models.

This episode features discussion around 3 recent announcements from Novo Nordisk, Eli Lilly, and Structure Therapeutics.

Stay updated with the latest healthcare breakthroughs, including FDA actions and new phase 3 data, in this week’s essential news roundup.

FDA clears setmelanotide for acquired hypothalamic obesity for ages 4 years and older, delivering 15.8% BMI drop in TRANSCEND.

The first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist delivered superior A1C reduction and weight loss at 40 weeks in people with type 2 diabetes.

ATTD 2026 reveals AI “digital twins,” next-gen closed-loop pumps, and sensors that boost time-in-range and ease diabetes management.

The MiniMed Flex is a discreet, smartphone-controlled insulin pump that is roughly the size of 2 stacked insulin vials.

New data show tegoprubart enabled insulin independence and strong glycemic control in adults with long-standing type 1 diabetes undergoing islet transplantation.

Data from the ACCESS II trial, ACCESS extension study, and a body composition study provide an early look at efficacy and safety data of a new investigational oral GLP-1.

Bialo discusses her perspective on the importance of T1D screening and its capacity to reduce the risk of disease progression and eventual complications later in life.

Tozzi and Wallach discuss ways to omit artificial sweeteners and added sugars from children’s diets and minimize risk for T2D and MASLD later in life.

Alexander discusses his recent study comparing 61 trials of 4 main GLP-1 RAs, highlighting their increased efficacy for weight loss in female patients.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.




































































