The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

Food and Drug Administration officials plan to present data they claim links the Covid vaccine to 25 deaths in children at what’s expected to be a closely watched vaccine advisory committee next week, ...

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...