2026 Global Regulatory Trends Shaping Oligonucleotide API Development and Compliance

As oligonucleotide therapies enter a critical growth phase—expanding from rare diseases to large indications like cardiovascular and metabolic disorders—the regulatory landscape is evolving rapidly to balance innovation, patient safety, and supply chain resilience. In 2026, key regulatory bodies worldwide are implementing landmark reforms and targeted guidelines that directly impact oligonucleotide active pharmaceutical ingredient (API) development, […]

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