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REGULATORY
- MHLW Issues Guidance on Clinical Trial Design for Radiopharmaceuticals
August 4, 2025
- Wage-Based Price Premiums on Drugs Not an Option, Says MHLW Insurance Chief
August 4, 2025
- Japan Panel OKs Taisho’s Insomnia Med, 2 Other NMEs for Approval
August 1, 2025
- MHLW Selects 20 Organizations to Bolster Drug Discovery Clusters
August 1, 2025
- MHLW Orders Label Revisions for Semaglutide, Tirzepatide to Include Ileus Risk
July 31, 2025
- 23 Suspected Promotional Violations Identified for 18 Drugs in FY2024: MHLW
July 31, 2025
- MHLW Panel to Further Review Positioning of Susmed’s Insomnia App
July 31, 2025
- MHLW to Link GS1 and YJ Codes in Public Database, Launch Planned for FY2028
July 30, 2025
- MHLW Raises Drug R&D, Supply Stability as FY2026 Budget Priorities
July 30, 2025
- OTC-Like Drugs Flagged as Key Agenda Item by CEFP Members
July 29, 2025
- Post-Marketing Oversight and Regulatory Reviews Must Work as One, Says New MHLW Safety Chief
July 29, 2025
- Astellas Employee Did Not Appeal, Prison Sentence Finalized in China
July 29, 2025
- Japan Panel Urges Consolidation of Cancer Surgery, Radiotherapy amid Shrinking Surgeon Workforce
July 29, 2025
- Two Oral Drugs Found to Exceed ADI for Red No. 3, MHLW Reports
July 28, 2025
- PMDA Launches Advisory Program for Academia, Startups Developing New Modalities
July 28, 2025
- MSD’s 21-Valent Pneumococcal Shot Nears Japan Approval; Male Use of Silgard 9 Cleared
July 25, 2025
- Santen’s Glaucoma Drug, Taisho’s Insomnia Med Up for Panel Review on July 31
July 25, 2025
- MHLW Calls for Ongoing Nitrosamine Risk Controls after Self-Inspections
July 24, 2025
- 223 Health Damages Reported for Breyanzi in Japan: October-March
July 24, 2025
- MHLW Plans to Ease Clinical Trial Ad Rules, Eyes Notification by March-End
July 24, 2025
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
