A fair question from the floor At a conference recently, someone asked me a question I […]
In our last post, we asked whether NAMs can really replace animals. The answer was yes, […]
Regulators have made their position clear. The FDA, UK, and EU have all published formal plans […]
The US has set the pace in moving drug development beyond animal testing. The FDA’s 2025 […]
Asking how accurate animal testing is will produce a strong response from many in pharmaceutical research. […]
Weight-of-Evidence has become a key phrase in drug development. It shows up in nearly every New […]
Every FDA-approved T cell-engaging bispecific antibody carries a boxed warning for cytokine release syndrome (CRS). Seven […]
On 14 July 2026, Bellberry and ASCEPT released the draft of their NAMs HREC Review Checklist: […]
In a previous post, I argued the competitive stakes. Operation TrialBlazer names Australia’s speed as the […]
Everyone is talking about the FDA’s proposed accelerated IND program. They are missing the startling document […]