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Regulatory requirements continue to evolve across global markets. Keeping pace with changes from the FDA, EMA, MHRA, PMDA, NMPA and other health authorities is critical for successful product development and lifecycle ma...

More than half of FDA authorisations for AI-enabled software as a medical device have occurred since 2022. Radiology continues to dominate, but the future of AI-enabled healthcare extends far beyond imaging. The next gen...

Before choosing a ctDNA assay for their oncology trial, biotechs face a consequential decision: whether ctDNA belongs in their trial as an exploratory endpoint or as a "reasonably likely" surrogate. The two paths carry v...

For neurologic mAbs, approval and access aren't the same thing. For example, Medicare coverage for anti-amyloid Alzheimer's therapies depends on registry enrolment of each patient before the first dose is administered. R...

What could acceptance of biomarker-based surrogates mean for biotechs pursuing tumor-agnostic therapies? Find out more in our article exploring how liquid biopsy based biomarkers are being leveraged in tumor agnostic tri...

A meeting room looked a little different in our Buenos Aires office this week. Instead of presentations and project discussions, colleagues rolled up their sleeves to take part in a blood donation drive hosted on site. ...

Current GLP-1 therapies have a high patient attrition rate within the first year. Prohibitive costs, safety concerns, lack of efficacy for some patients, and severe GI side effects like nausea & vomiting are drivers. Lea...

Research publishing made easier. PubsHub PMSolution automates project management support. The system offers a streamlined interface and review process with robust reporting capabilities to keep your work and contributors...

The real promise of AI in healthcare is not the technology itself. It is the potential to help clinicians make better decisions, improve patient outcomes and deliver more personalised care. As AI-enabled medical devices ...

What happens when regulatory approval outpaces reimbursement? ICON authors Elizabeth Madichie and Jack Martin explore the growing divergence between regulators and payers in accelerated approval pathways and how smarter ...

Global success starts long before a regulatory submission. In PharmaTimes Magazine, ICON discusses how APAC sponsors can design studies with global authorisation in mind, helping ensure clinical data meets the expectatio...

What happens when regulatory requirements compete for space on a medical device label? In the third instalment of MedTech Insight's PPWR series, ICON contributors Claudia Anzaldo and Véronique Boscher (Perrin) discuss t...