Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian De...
New/Key MDCG guidances in 2024
The European Commission continues to refine and expand regulatory ...
Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024
USA
FDA approves neoadjuvant/adjuvant nivolumab for resectable non...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024
USA
Guidance on Considerations for Long-Term Clinical Neurodevelop...
Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA
FDA Approves Drug with New Mechanism of Action for Treatment o...
