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FDA Approves Rybelsus for Cardiovascular Risk in Diabetes

10/20/2025

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Summary

Story summary

The Food and Drug Administration (FDA) approved Novo Nordisk's Rybelsus for cardiovascular risk reduction in adults with type 2 diabetes at high risk of heart attack or stroke.
The SOUL trial showed a 14% reduction in major adverse cardiovascular events with the 14 mg dose over four years.
Novo Nordisk seeks FDA approval for a higher-dose obesity treatment, with a decision by end of 2025.

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Story summary

The Food and Drug Administration (FDA) approved Novo Nordisk's Rybelsus for cardiovascular risk reduction in adults with type 2 diabetes at high risk of heart attack or stroke.
The SOUL trial showed a 14% reduction in major adverse cardiovascular events with the 14 mg dose over four years.
Novo Nordisk seeks FDA approval for a higher-dose obesity treatment, with a decision by end of 2025.