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FDA Mandates New Eye Risk Warnings for GLP-1 Receptor Agonists

FDA Mandates New Eye Risk Warnings for GLP-1 Receptor Agonists

The U.S. Food and Drug Administration (FDA) has mandated that manufacturers of GLP-1 receptor agonist (GLP-1 RA) medications, including popular drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, add information about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) to the Warnings and Precautions section of their labeling. This decision, announced on Monday, November 9, 2026, follows an FDA assessment that included 126 clinical trials involving over 134,000 patients, animal data, real-world data, and published observational studies. NAION is a serious eye condition characterized by sudden, painless vision loss, which can be permanent and currently has no proven treatments. While FDA scientists could not identify a specific mechanism linking GLP-1 drugs to NAION, the agency concluded that the potential increased risk warranted additional warnings across the drug class.
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Do Ozempic, Zepbound cause vision loss? New FDA warning explained

Do Ozempic, Zepbound cause vision loss? New FDA warning explained

A rare eye condition that causes vision loss has been added to GLP-1 warning labels in the United States. Here's what it means.
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FDA says popular GLP-1 drugs linked to rare risk of vision loss, blindness

FDA says popular GLP-1 drugs linked to rare risk of vision loss, blindness

The FDA said GLP-1 drugmakers must add labels warning of NAION, a rare condition that can lead to decreased vision and blindness.
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US FDA orders new eye risk warnings for Ozempic, Zepbound

US FDA orders new eye risk warnings for Ozempic, Zepbound

Nov 9 (Reuters) - The US health regulator on Monday informed patients and healthcare providers of a potential increased risk of a serious eye condition associated with the use of GLP-1 drugs for weight loss and diabetes.
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Roche Initiates Phase II Clinical Trial for Alzheimer's Drug Targeting Neuroinflammation

Roche Initiates Phase II Clinical Trial for Alzheimer's Drug Targeting Neuroinflammation

Roche has announced the initiation of a new Phase II clinical trial, TARBELA-AD, to evaluate RG6434, an investigational oral NLRP3 inhibitor, for early symptomatic Alzheimer's disease. This study is part of Roche's broader strategy to address Alzheimer's by targeting various biological mechanisms, specifically focusing on neuroinflammation as a key driver of pathology in addition to amyloid aggregation. The announcement was made in anticipation of the 19th Clinical Trials on Alzheimer's Disease (CTAD) Congress in Boston, scheduled from November 16-19, 2026. According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, this trial aims to test additional therapeutic hypotheses to potentially halt or prevent disease progression, complementing their ongoing trontinemab programs. Roche's diagnostics division is also expanding access to earlier and more accurate Alzheimer's diagnosis through its blood-based biomarker portfolio, including the FDA-cleared Elecsys pTau217 and Elecsys pTau181 tests.
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Ozempic SELECT Trial Shows 20% Cardiovascular Event Reduction, But Muscle Loss and Weight Regain Concerns Emerge

Ozempic SELECT Trial Shows 20% Cardiovascular Event Reduction, But Muscle Loss and Weight Regain Concerns Emerge

The SELECT trial, published in the New England Journal of Medicine in 2023, demonstrated that semaglutide (the active ingredient in Ozempic and Wegovy) led to a 20% relative reduction in a composite outcome of cardiovascular death, nonfatal heart attack, and nonfatal stroke. The study involved 17,604 adults with existing cardiovascular disease, a BMI of 27 or higher, and no diabetes, who were followed for an average of 40 months. While this 20% relative reduction is statistically significant, the absolute difference was 1.5 percentage points (6.5% in the semaglutide group vs. 8.0% in the placebo group). However, concerns have been raised regarding muscle loss during weight reduction and significant weight regain upon discontinuation of the drug. The STEP 1 trial indicated that nearly 40% of the weight lost was lean mass, and participants regained approximately two-thirds of their lost weight within a year of stopping semaglutide.
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Merck Announces Positive Phase 2b Results for Efinopegdutide in MASH with Fibrosis

Merck Announces Positive Phase 2b Results for Efinopegdutide in MASH with Fibrosis

Merck Announces Positive Phase 2b Results for Efinopegdutide in MASH with Fibrosis
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BioVie to Present Positive Bezisterim Data for Parkinson's Disease at International Conference

BioVie to Present Positive Bezisterim Data for Parkinson's Disease at International Conference

BioVie Inc., a clinical-stage biopharmaceutical company, is scheduled to present new data on its investigational drug, bezisterim (NE3107), at the AD/PD2027 International Conference on Alzheimer's & Parkinson’s Diseases in Barcelona, Spain, from March 16-20, 2027. The presentations will focus on exploratory analyses from the Phase 2 SUNRISE-PD trial, which evaluated bezisterim in 57 patients with early-stage Parkinson's disease. The study found that patients with higher systemic inflammation at baseline, defined by platelet counts above 230 × 10^9/L, showed significant improvements in both motor and non-motor symptoms of Parkinson's disease. Specifically, this subgroup experienced better scores in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I (non-motor), Part III (motor), and Total Scores. The drug works by modulating key pathways involved in neuroinflammation and improving insulin sensitivity without suppressing the immune system.
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FDA adds rare vision-loss warning to popular GLP-1 drugs

FDA adds rare vision-loss warning to popular GLP-1 drugs

The Food and Drug Administration is adding a new warning about possible rare cases of vision loss reported with popular drugs used for weight loss and diabetes, such as Ozempic
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Pfizer Advances GLP-1 Drug Development with Focus on Monthly Dosing

Pfizer Advances GLP-1 Drug Development with Focus on Monthly Dosing

Pfizer Advances GLP-1 Drug Development with Focus on Monthly Dosing
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Novo Nordisk Raises 2026 Sales and Profit Outlook Amid Strong Obesity Treatment Demand

Novo Nordisk Raises 2026 Sales and Profit Outlook Amid Strong Obesity Treatment Demand

Novo Nordisk Raises 2026 Sales and Profit Outlook Amid Strong Obesity Treatment Demand
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Your job-based insurance cut GLP-1 coverage. Here are some options

Your job-based insurance cut GLP-1 coverage. Here are some options

Companies are cutting health insurance coverage for weight-loss drugs Wegovy and Zepbound. Consumers are scrambling to pay for pricey GLP-1 drugs.