In the first half of 2025, the FDA approved 16 novel therapies, with 10 of these being orphan drugs for rare diseases—demonstrating a clear focus on this area. 🌟

To put this into perspective, orphan drugs made up 47% of novel therapies in 2024 and 49% in 2023. This year, if the current trend continues, 2025 will mark a significant milestone with orphan drugs representing 62.5% of novel therapy approvals! 🚀

Rare diseases are finally stepping into the spotlight as major regulatory bodies, including the WHO, recognize them as global health priorities. 🌍 Recent FDA initiatives and updated policies aim to accelerate and expedite rare disease drug development, streamline regulatory pathways, and provide enhanced incentives for innovation. ⚖️✨

As rare diseases gain global recognition and regulatory support, Clinakos stands ready with robust, regulatory-grade, AI-powered, patient-centric data to support the latest wave of orphan drug development. 🤖📊

With orphan drugs representing over 60% of novel therapies approved so far in 2025, the landscape is evolving rapidly. Our data solutions and insights are designed to empower sponsors and researchers navigating this dynamic environment. 💡🔬

Reach out to us to learn more at [https://lnkd.in/gp3gUmXc] 

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