Paravathaneni M, Safa H, Joshi V, et al. 15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and ...

The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

Q2 2025 Management View President and CEO James E. Dentzer stated that "we continue to make steady progress in our TakeAim Lymphoma study, which is evaluating emavusertib in combination with ibrutinib ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

We collected data from the included studies on changes in reported trends after the FDA antidepressant warnings with respect to the single intended outcome of the policy: prescriber monitoring of ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data ...