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 […]
Three jurisdictions, three emphases: NAMs, timelines, and chemicals. Three major regulatory jurisdictions have now published formal […]
A question posed during a debate at the MPS World Summit last week really stuck with […]
Global regulators have spent the last two years making their position on New Approach Methodologies (NAMs) […]
The past 12 months have shown an incredible focus on New Approach Methodologies (NAMs) to reduce […]
The flurry of attention New Approach Methodologies (NAMs) have recently received has come with a range […]