In June 2024, the World Health Organization (WHO) issued a medical product alert regarding the increased reports of falsified semaglutide products across various regions. Healthcare professionals and regulatory authorities were advised to remain vigilant and ensure the authenticity of semaglutide products to safeguard patient safety.
In June 2025, the WHO highlighted the risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with semaglutide use. The European Medicines Agency (EMA) recommended updating the product information for semaglutide-containing medicines to include NAION as a very rare side effect. Healthcare providers were advised to monitor patients for visual disturbances and counsel them on this potential risk.
In January 2026, the EMA's CHMP adopted a positive opinion recommending the conditional marketing authorization of Kayshild, a semaglutide product for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). This development signifies the expanding therapeutic applications of semaglutide beyond diabetes and obesity management.
In February 2026, the WHO published the 24th edition of the Model List of Essential Medicines, which did not include semaglutide. The list comprises over 520 medicines selected based on public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. While semaglutide's exclusion may influence its prioritization in certain health systems, its proven benefits in managing type 2 diabetes and obesity continue to drive its global demand.
In March 2026, the FDA approved a new indication for semaglutide, expanding its use to include the treatment of adolescents with type 2 diabetes. This approval reflects the growing recognition of semaglutide's efficacy and safety profile across different patient populations.
These developments underscore the dynamic regulatory landscape surrounding semaglutide, highlighting the importance for stakeholders to stay informed and adapt to evolving standards and guidelines.
