The Weekly Dose: New CKM Syndrome Guidelines, ASCO and ADA Conference Coverage, and FDA Approvals

In this episode of The Weekly Dose, hosts Danielle Valletti and Kennedy Ferruggia at Pharmacy Times break down major clinical, conference, and regulatory updates shaping pharmacy practice.

The top story focuses on a landmark joint guideline published by the American Heart Association, American College of Cardiology, American Diabetes Association, and American Society of Nephrology establishing the first evidence-based framework for cardiovascular-kidney-metabolic (CKM) syndrome. The guideline introduces a 4-stage CKM classification system to help clinicians identify risk earlier and intervene before patients progress to advanced cardiovascular disease. It formally incorporates glucagon-like peptide-1 (GLP-1) receptor agonists for select patients with obesity and type 2 diabetes (T2D) and specifically highlights the critical role pharmacists can play in coordinating therapy, monitoring outcomes, and improving adherence across the CKM spectrum.

The episode also recaps Pharmacy Times coverage from 2 major conferences. At ASCO 2026 in Chicago, highlights included phase 3 data from the Proteus trial on perioperative apalutamide (Erleada; Janssen) in high-risk localized prostate cancer and new findings from the PRESERVE trial evaluating elacestrant plus palbociclib in ER-positive, HER2-negative metastatic breast cancer, a combination now under FDA priority review. At ADA 2026 in New Orleans, a notable presentation showcased a pharmacist-led refill authorization program that eliminated approximately 3750 refill requests from endocrinology provider inboxes in 2025. Expert commentary also previewed proposed updates to ADA and EASD hyperglycemia guidance, including earlier use of GLP-1 receptor agonists and SGLT-2 inhibitors at the time of T2D diagnosis.

On the regulatory front, the FDA approved insulin human (Afrezza; MannKind Corporation) inhalation powder for pediatric patients aged 6 and older with T1D or T2D—the first inhaled insulin approved for this age group—and approved ensiltresvir (Xocova; Shionogi & Co, Ltd) as the first oral antiviral for post-exposure prophylaxis of COVID-19. Additionally, the FDA granted breakthrough therapy designation to VER-01, an investigational cannabis-derived treatment for chronic low back pain, following positive phase 3 findings.