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CDMOs with a global footprint are particularly well-positioned to navigate this landscape, as they often have established relationships with regulators and a proven track record of compliance across multiple jurisdictions
In 2025, Novo Nordisks semaglutide awaits several first-time FDA decisions: 3Q 2025 the first GLP-1 (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) 4Q 2025 the first oral GLP-1 ( oral formulation of Wegovy 25 mg ) for weight loss and weight loss plus secondary CV risk reduction 4Q 2025 Wegovy for heart failure with preserved ejection fraction and obesity October 2025 new indication for oral Rybelsus for secondary CV risk reduction 2025 Ozempic for T2DM and peripheral artery disease (PAD) Given the considerable continued growth expected in the GLP-1 pipeline, Prime Therapeutics (Prime) talented team of clinical experts actively monitors this emerging landscape
Ongoing research continues to refine our understanding of this potential complication, and clinicians should remain vigilant for emerging safety data while balancing the substantial metabolic benefits these medications provide for appropriate patients
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