Ryan Livingston

Eli Lilly’s investigative GLP-1/GIP/glucagon triple agonist has demonstrated its efficacy in reducing several major factors of obesity versus placebo.

Eli Lilly’s investigative GLP-1/GIP/glucagon triple agonist has outperformed placebo in patients with poorly-controlled T2D.

Teplizumab, which has recently seen a substantial label expansion into pediatric patients, is matching its safety and efficacy data in the clinic.

Catch up on major trial results, key FDA decisions, and more.

May 2026 saw substantial FDA decisions, major trial results, guideline updates, and more.

View the top 6 trials to watch ahead of a star-studded ADA 2026.

Phase 3 post hoc data linked lorundrostat to lower systolic blood pressure and albuminuria in patients with hypertension and CKD.

FDA accepted a priority review sNDA for mavacamten in adolescents with symptomatic obstructive hypertrophic cardiomyopathy.

The FDA has approved fast-acting inhaled insulin Afrezza for pediatric patients aged 6-18 years with T1D or T2D.

Saroglitazar received FDA Priority Review for adults with PBC after phase 3 data showed improved biochemical response versus placebo.

FDA De Novo classification clears Cardiosense PCWP Analysis Software to estimate filling pressures in selected adults with HFrEF.

Lilly reports dose-dependent PCSK9 and LDL-C reductions with single-dose VERVE-102 in interim phase 1b hypercholesterolemia data.

The FDA accepted Bayer’s sNDA for finerenone in adults with type 1 diabetes and CKD based on albuminuria data from FINE-ONE.

Retatrutide successfully reduced body weight versus placebo in adults with obesity or overweight in topline phase 3 TRIUMPH-1 results.

FDA granted priority review to asundexian for secondary prevention after non-cardioembolic ischemic stroke or TIA.

FDA approved baxdrostat as add-on therapy for adults with hypertension not controlled on other medications.

The FDA has cleared the EndoTool IV Cloud for hospital IV insulin dosing support, expanding Glooko’s inpatient platform via the 510(k) pathway.

The NDA submission follows positive results from the CALIBRATE phase 3 trial, which evaluated encaleret versus standard-of-care in adults with ADH1.

This FDA News Month in Review provides a round-up of regulatory decisions from April 2026.

Patient education may be the missing piece needed to bridge the gap between hypertension treatments and improved outcomes.

The new recommendations outline glucocorticoid tapering strategies for adults and children with classic CAH after starting crinecerfont.

Catch up on key clinician insights, major FDA decisions, groundbreaking trial results, and more.

Catch up on any data and perspectives presented at the American Association of Clinical Endocrinology Annual Meeting 2026.

April 2026 saw further updates from ACC.26, plus key trial results, guideline updates, and more.

The FDA granted Fast Track Designation to coramitug, an investigational anti-TTR antibody designed to clear existing amyloid deposits in ATTR cardiomyopathy.

FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.

Recent data presented at AACE 2026 have indicated the efficacy of GLP-1 RA treatment in reducing risk of diabetic retinopathy, renal disease, and others.

A recent study presented at AACE 2026 has displayed the IGF-1R’s capacity for improving proptosis and disease activity in patients with poorly-controlled TED.

A recent presentation at AACE 2026 highlights the drastically increased risk of mortality, sepsis, diabetic ketoacidosis, and recurrent acute pancreatitis after GLP-1 initiation.

A recent study from AACE 2026 has indicated the value of bariatric surgery in adults with type 1 diabetes – and emphasized the need for closer perioperative management.