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

In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control ...

The FDA’s green light for a Phase II trial (JSKN003-202) of JSKN003 accelerates efforts to address platinum-resistant ovarian ...

In a pre-specified sub-study of the BROADWAY trial, obicetrapib 10 mg significantly reduced plasma p-tau217 levels in patients with ASCVD, including ApoE4 carriers, suggesting dual potential to lower ...

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how biopharma companies—especially ...

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

Rachel Smith Executive Director Rare Disease Center of Excellence Parexel International Ms. Smith brings more than a decade of experience in every development phase of rare disease and cell and gene ...

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with ...

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in ...

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials ...

In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory ...