Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set ...

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical ...

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit ...

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, explains how ...

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how real-time data access is helping biotechs accelerate trial timelines, ensure ...

The Phase I/II trial will evaluate the safety and early efficacy of ABT-301 in combination with tislelizumab and bevacizumab ...

Managing Director at NFP ...

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

Sponsors should be aware of the significant implications the Addendum is likely to have on clinical trial planning, conduct, statistical analysis, and interpretation.

Conducting Large Simple Trials to answer questions about "real-world" medical interventions is not a recent concept.