Results from the Phase III PREVAIL trial (NCT05556096) of gefurulimab demonstrated a statistically significant and clinically ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research ...

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

Results from the Phase III ABTECT-1 (NCT05507203) and ABTECT-2 (NCT05507216) trials showed that Abivax’s obefazimod demonstrated significant clinical remission in patients with ulcerative colitis.

Astegolimab met its primary endpoint in the Phase IIb ALIENTO trial with a 15.4% reduction in annualized exacerbation rate at 52 weeks, while the Phase III ARNASA study showed a 14.5% reduction and ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical ...

How modeling and simulation clarified complex exposure levels and an orphan drug got approved.

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

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced ...

New long-term data from the Phase III FLAURA2 trial confirm that Tagrisso combined with chemotherapy delivers a significant overall survival benefit over monotherapy in patients with advanced ...