Endocrinology

With the new drug application accepted with priority review, the FDA has assigned a date of November 20, 2025, to complete its review for potential approval.

The decision makes hydrocortisone oral solution (Khindivi; Eton Pharmaceuticals) the only FDA-approved oral formulation of hydrocortisone.

Somapacitan was non-inferior and had a similar safety profile and clinical outcomes compared to once-daily somatropin in improving yearly growth rates.

Most want to start the conversation, but confidence and timing vary.

The FDA is warning diabetes patients that information from CGMs, insulin pumps, and automated dosing systems could fail to be delivered if smartphone settings are not properly configured.

The primary endpoint was non-inferiority in HbA1c levels after 26 weeks.

A further understanding of the role SARS-CoV-2 plays in T2D incidence can add an important component to benefit and risk considerations to prevent COVID-19.

Look back at several quick video interviews discussing the expanding role of artificial intelligence, how RSV treatment has evolved, and much more.

This decision marks the second time the FDA has issued a complete response letter (CRL) for dasiglucagon to treat hypoglycemia in patients 7 days and up with congenital hyperinsulinism.

The USPSTF statement aligns with the 2015 recommendation on insufficient evidence for pregnancy iron deficiency screening or supplementation.

The most common comorbid conditions were endocrinopathies (10%), trisomy 21(5%), and attention-deficit/hyperactivity disorder (4%).

Diamyd to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2 was granted Fast Track designation by the FDA in February 2024.

"Taken together, our findings suggest the relative protection associated with having a mother versus father with type 1 diabetes is a long-term effect that extends into adult life," stated study investigators.

The decision is based on statistical significance achieved in the T2NOW trial, which demonstrated reduction of A1C.

The primary outcome was an elevated HbA1c level greater than or equal to 5.7% (prediabetes or undiagnosed presumed T2D).

Drugs like semaglutide and liraglutide were dispensed at unprecedented increased rates for adolescents and young adults over a span of just 4 years.

Investigators found that higher baseline HbA1c was associated with greater T2D risk.

The FDA has approved lutetium Lu 177 dotatate for pediatric patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Lara Smith, DNP, APRN, CPNP-AC/PC, provides case-based examples of endocrine emergencies in the pediatric ICU, based on her session presented at the 45th NAPNAP National Conference.

A qualitative analysis shows adolescents and their parents more frequently report an unreadiness to transition from pediatric to adult type 1 diabetes care.

Crinecerfont, an investigational, oral, selective corticotropin-releasing factory type 1 receptor antagonist, achieved the primary and key secondary endpoints in a phase 3 study to treat congenital adrenal hyperplasia due to 21-hydroxylase deficiency in children aged 2 to 17 years.

According to the study, maintaining modest residual beta cell function in newly diagnosed patients is associated with a lower risk of vascular complications and hypoglycemia. 

The US FDA announced the approval of teplizumab (Tzield), which is administered through IV infusion once daily for 14 consecutive days, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

An analysis of data from more than 9900 people with Down syndrome and 38,000 controls provides new insight into the apparent increase in risk of developing diabetes among children and young adults with Down syndrome.

Results of the TARGET trial provide insight into the effects of tight glycemic targets versus less tight targets on maternal and perinatal outcomes among women with gestational diabetes.

Investigators found minimal difference between breastfeeding rates less than 1 week postpartum of women who had diabetes pre-pregnancy, gestational diabetes only, and no history of diabetes.

New research suggests adolescent obesity could increase risk of type 1 diabetes in young adulthood.

An analysis of the SEARCH for Youth in Diabetes details historic and contemporary disparities in insulin pump use for pediatric type 1 diabetes based on racial/ethnic background, household income, and insurance type.