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We’re excited to be part of #SCDMChina this year, taking place from 3 - 4 July in Shanghai. Visit booth \#6 tomorrow to meet our team and learn how ICON is revolutionising clinical research with cutting-edge data-driven ...

Oligonucleotide (ON) drug development is accelerating rapidly—but first‑in‑human (FIH) studies remain complex. Listen to our recent webinar where specialists discussed: - Translational PK/PD and toxicity considerations ...

The recent implementation of ICH Q5A(R2) marks the most consequential shift in viral safety for biotechnology products since the 1990s, moving sponsors toward risk based, technology enabled controls that can shorten test...

Many molecularly guided treatments with tumor-agnostic potential are still modulated by lineage-specific biology. Emerging tools that predict whether a molecular target is appropriate for tumor-agnostic development could...

Global trends for drug-device combination product regulation are moving toward an integrated approach, shifting away from quality systems that prioritise just one component of the combination. From integrated quality sy...

How will the latest regulatory changes impact your biosimilar strategy? The March 2026 updates from the EMA and FDA are redefining expectations — from reduced reliance on comparative efficacy studies to more streamlined...

The shift towards real-time clinical trials could reduce long-standing inefficiencies in data flow and accelerate early decision-making. However, greater transparency also introduces new challenges in governance, data ma...

Attending CTO East Coast? Visit us at Booth \#18 and see how ICON Biotech partners with sponsors to address the complexities of drug development through customized solutions, functional expertise and consistent delivery....

Choosing the right biomarkers is central to advancing tumor‑agnostic therapies. Liquid biopsy‑based approaches could provide the sensitivity, specificity, and accessibility required to support both screening and outcomes...

From harmonised labelling requirements to new recyclability standards, the PPWR will reshape how packaging is designed, managed and governed across the EU. With key milestones beginning in August 2026, early preparation...

Japan has implemented several reforms over the last several years to establish a modernised clinical trial ecosystem that supports simultaneous global development. Explore these reforms, including multi-regional clinical...

Latest issue now available. Join thousands of subscribers who have discovered the convenience of our free monthly publication, by signing up today https://ow.ly/Hxx750Zi8bm. Compiled and collated by ICON’s Regulatory ...