Rare and Neglected Diseases Archives

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Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe

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Danielle PillsburyFebruary 28, 2025

Video

Accelerating CMC Success in Rare Disease Drug Development

New drug approvals in rare diseases are rising, bringing hope to patients. But with accelerated…

CertaraFebruary 26, 2025

Video

Leveraging Real-World Evidence (RWE) in Rare Disease Drug Development

The path to regulatory approval and market access for rare disease therapies presents unique challenges.…

CertaraFebruary 26, 2025

Video

Bridging Global Health Disparities in Rare Disease Drug Development

Rare diseases know no borders—but access to life-changing treatments remains unequal across the world. In…

CertaraFebruary 26, 2025

Video

Advancing Rare Disease Therapies: The Power of Regulatory Expertise

Bringing treatments to patients with rare diseases has long been one of the biggest challenges…

CertaraFebruary 26, 2025

Video

How Biosimulation is Transforming Rare Disease Drug Development

Developing therapeutics for rare diseases comes with unique challenges—small patient populations, high variability in treatment…

CertaraFebruary 26, 2025

Video

Gene Therapy: A Transformative Shift in Rare Disease Treatment

After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…

CertaraFebruary 26, 2025

Video

Navigating Rare Disease Regulations: Challenges, Opportunities, and Innovative Solutions

Bringing life-changing therapies to rare disease patients requires expertise, innovation, and a deep understanding of…

CertaraFebruary 26, 2025

Fact Sheet

The Tools You Need to Accelerate Rare Disease Drug Development

Danielle PillsburyFebruary 20, 2025

Blog

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…

CertaraJanuary 10, 2025

Rare and Neglected Diseases

Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe

Accelerating CMC Success in Rare Disease Drug Development

Leveraging Real-World Evidence (RWE) in Rare Disease Drug Development

Bridging Global Health Disparities in Rare Disease Drug Development

Advancing Rare Disease Therapies: The Power of Regulatory Expertise

How Biosimulation is Transforming Rare Disease Drug Development

Gene Therapy: A Transformative Shift in Rare Disease Treatment

Navigating Rare Disease Regulations: Challenges, Opportunities, and Innovative Solutions

The Tools You Need to Accelerate Rare Disease Drug Development

Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters

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