Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has flagged new safety risks under evaluation for a batch of products including five anticoagulants for splenic hemorrhage leading to splenic rupture. The five blood-thinning agents under review are apixaban, edoxaban tosilate hydrate,…
To read the full story
Related Article
REGULATORY
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
- Aspirin, CAR-T and Other Products under PMDA Safety Review
December 8, 2025
- R&D Tax Credit Draws Broad Calls for Maintenance, Expansion: LDP Meeting
December 8, 2025
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…





