GlobalData on MSN

FDA prevails over EMA in 2025 novel drug approvals

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
pharmaphorum

EMA and FDA agree 'principles' for AI in drug development

Top of the list is that AIs must be human-centric by design and align with ethical values. They must be developed using a ...
PharmTech

EMA and FDA Collaborate on Framework for AI Use in Drug Development

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
GlobalData on MSN

FDA and EMA release collaborative AI framework for drug development

"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Pharmaceutical ...
Medscape

From Diabetes to Duchenne: EMA’s Defining 2025 Drug Calls

The European regulator’s anniversary year featured first-in-class therapies, rare-disease advances, safety warnings, and new ...

EMA and FDA present guidelines for AI in drug development

EMA and FDA define ten principles for AI use in medicines – in response to growing pressure from the industry.