FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition FDA Drug Safety Communication – November 9, 2026

https://www.fda.gov/drugs/drug-safety-communications/fda-requires-safety-labeling-changes-glucagon-peptide-1-receptor-agonists-glp-1-ras-due-potential?utm_medium=email&utm_source=govdelivery What Safety Concern is FDA Announcing? The U.S. Food and Drug Administration is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss.

AI in Medicine: Transforming the Landscape of Tissue-Based Diagnostics GRIDS 2025

https://checkrare.com/learning/p-grids2025-session1-ai-in-medicine-transforming-the-landscape-of-tissue-based-diagnostics/

Mirum’s Livmarli Achieves Primary Endpoint in Phase 3 EXPAND Study by Chad Birt| Published on: Nov 2, 2026

Mirum’s Livmarli Achieves Primary Endpoint in Phase 3 EXPAND Study by Chad Birt| Published on: Nov 2, 2026 Mirum Pharmaceuticals recently announced positive topline results from its phase 3 EXPAND study, evaluating Livmarli (maralixibat) for cholestatic pruritus in patients six months and older with ultra-rare cholestatic liver diseases. Jennifer Vittorio, MD, an EXPAND investigator, an Associate Professor of Pediatrics, and the Medical Director of Pediatric Liver Transplantation at NYU Langone Health, discusses the findings. https://checkrare.com/mirums-livmarli-achieves-primary-endpoint-in-phase-3-expand-study/

Garetosmab Demonstrates Sustained Efficacy in Adults With Fibrodysplasia Ossificans Progressiva (FOP) by Chad Birt| Published on: Nov 9, 2026

Garetosmab Demonstrates Sustained Efficacy in Adults With Fibrodysplasia Ossificans Progressiva (FOP) by Chad Birt| Published on: Nov 9, 2026 Richard Keen, MD, PhD, Director of the Metabolic Bone Disease Centre at the Royal National Orthopaedic Hospital in London and global principal investigator of the OPTIMA trial, discusses positive 84-week results from the phase 3 OPTIMA trial extension, evaluating Pasatru (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva (FOP). https://checkrare.com/garetosmab-demonstrates-sustained-efficacy-in-adults-with-fibrodysplasia-ossificans-progressiva-fop/

Refining Adjuvant Therapy in HR-Positive/HER2-Negative Early Breast Cancer: Personalizing Care in the CDK4/6 Inhibitor Era Authors: Nadia Harbeck, MD, PhD; Frédérique Penault-Llorca, MD; Giampaolo Bianchini, MD; Henry Cain, MBChB, FRCS, MD; Janice Walshe, MB BCh, BAO, MRCPI

https://www.medscape.org/viewarticle/refining-adjuvant-therapy-hr-positive-her2-negative-early-2026a1000ysl?page=1&src=mkmcmr_driv_stan_mscpedu_261108-OUS-HONC-refining-adjuvant-therapy-hr-positive-her2-negative-early-2026a1000ysl-cta&uac=148436CN

Personalizing Patient Care in HR-Positive/HER2-Negative Breast Cancer Authors: Aditya Bardia, MD, MPH, FASCO

https://www.medscape.org/viewarticle/personalizing-patient-care-hr-positive-her2-negative-breast-2026a1000jqp?page=1&src=mkmcmr_driv_psims_mscpedu_261108-OUS-HONC-personalizing-patient-care-hr-positive-her2-negative-breast-2026a1000jqp-cta&uac=148436CN

Adding Chemotherapy to Pembrolizumab Extends Progression-Free Survival in Lung Cancer With High PD-L1 Expression

https://www.medscape.com/viewarticle/adding-chemotherapy-pembrolizumab-extends-progression-free-2026a100167j?src= The addition of platinum-based chemotherapy to pembrolizumab extended median progression-free survival (PFS) from 6.9 to 16.1 months in patients with previously untreated advanced non-small cell lung cancer (NSCLC) and PD-L1 expression of 50% or higher in a phase 3 trial. Severe treatment-related adverse events were more frequent with the combination.