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The RACE Act changed pediatric oncology in the US. The EMA’s proposed MoA PIP requirements could do the same in Europe. So what does this mean for sponsors? ICON’s Regulatory Affairs (Graham Bell) and Pediatrics (Jacqu...

Proposed requirements for Mechanism of Action based PIPs are coming. Right now, they’re still developing. ICON can help sponsors position to stay ahead of the curve and benefit from incentives while meeting pediatric obl...

As biosimilar portfolios expand, the need for sensitive and reliable bioanalytical methods has never been greater. Our latest spotlight explores evolving approaches that strengthen comparability assessments and support r...

Biosimilar development continues to expand, bringing greater analytical complexity. This spotlight examines the evolving regulatory environment and changing methodologies supporting robust, high confidence bioanalysis. ...

ICON will participate in BIO Korea 2026 from 28 to 30 April in Seoul, South Korea. The event brings together leaders in biotechnology and healthcare to discuss scientific innovation and industry collaboration. Visit ICO...

ICON will participate in BIO Korea 2026 from 28 to 30 April in Seoul, South Korea. The event brings together leaders in biotechnology and healthcare to discuss scientific innovation and industry collaboration. Visit ICO...

Strong engagement, open dialogue, and a shared focus on the future. Last week, ICON CEO, Barry Balfe, connected with teams in our São Paulo and Mexico City offices, hosting a series of highly engaged town halls. The vis...

Patient safety and data integrity are the primary concerns in early phase clinical trials. In the US sponsors generally follow one of two standards sets when conducting early phase trials: Good Manufacturing Practice (GM...

Patient safety and data integrity are the primary concerns in early phase clinical trials. In the US sponsors generally follow one of two standards sets when conducting early phase trials: Good Manufacturing Practice (GM...

Recent biosimilar regulatory changes have led to a perceived lower barrier to entry for developers of all sizes, introducing heightened competition. Read the whitepaper to learn how biosimilar developers can prepare fo...

In 2025, the EMA and FDA each released regulatory guidance that impacts the development and approval processes for biosimilars, such as by waiving the need for comparative clinical efficacy studies in some circumstances....

ICON is excited to sponsor RAPS Euro Convergence 2026, taking place 5–8 May in Lisbon. Visit us at booth \#21 to meet our team and discuss how ICON combines expertise and experience with the latest in productivity tool...