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.

Study design: only randomised controlled trials will be included in the study ... Figure 1 shows the PRISMA flow diagram of the literature selection in this study. Actual screening numbers will be ...

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, outlines her five-year vision for ...

While more companies are using real-world data (RWD) and real-world evidence (RWE) in research, there are still barriers that ...

Combining insulin treatment with the investigational drug dapagliflozin may improve health outcomes for adolescents with type ...

BACKGROUND: Whether cannabis is a risk factor for cardiovascular events is unknown. We examined the association between smoking cannabis and cardiovascular events in a cohort of older veterans (66 to ...

Worried about looming tariffs on tech? Our experts review more than 1,500 products each year. Our mega-guide, updated monthly ...

Design The study cohort comprised 89 healthy individuals and 496 HBV-infected patients, with subgroups of 30 and 42 participants receiving randomised nucleos(t)ide analogue (NA) and PegIFN-α ...

This study offers important insights into the development of infants' responses to music based on the exploration of EEG neural auditory responses and video-based movement analysis. The convincing ...