ICON’s June 2025 survey of more than 100 investigators and site leaders reveals persistent bottlenecks in study startup ...

Examine the rise of personalized and biomarker-driven therapies, the logistical challenges of rare patient populations, and ...

The FDA has launched a secure, GovCloud-based agentic AI system to support regulatory workflows across review divisions, ...

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong ...

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong ...

“FDA's talented reviewers have been creative and proactive in deploying AI capabilities—agentic AI will give them a powerful tool to streamline their work and help them ensure the safety and efficacy ...

In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...

Explore the challenges sponsors and CROs face in maintaining clinical reference data, uncover the hidden costs of traditional upkeep models, and see how integrated data solutions can streamline ...

In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the ...

The FDA has granted accelerated approval to Otsuka’s Voyxact for adults with primary IgAN at risk of disease progression, ...

In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...

Novo Nordisk's 7.2 mg Wegovy injectable aims to enhance chronic weight management in adults with obesity, using an expedited ...