Regulatory Affairs – Discover Pharma

Welcome to Discover Pharma! Today is : November 16, 2025

Regulatory Affairs

Biologics & Biosimilars,Chronic diseases,Clinical Development,Clinical Trials,Patient Centricity,Pharmaceuticals and therapeutics,Real world evidence,Regulatory Affairs
Saphnelo self-administration Phase 3 trial meets primary endpoint in systemic lupus erythematosus
AstraZeneca has reported positive interim results from the Phase 3 [...]

September 22, 2025
Clinical studies,Clinical Trials,Drug approval,Medical devices,Patient Centricity,Pharmaceuticals and therapeutics,Regulatory Affairs
Amber Implants secures FDA clearance for VCFix spinal system
Amber Implants has received FDA 510(k) clearance for its VCFix [...]

September 22, 2025
CDMOs & Manufacturing,Global health,Regulatory Affairs,Research & Development,Supply Chain & Logistics,Technology and platforms
Axplora expands Vizag API capacity and confirms FDA inspection success at Indian sites
Axplora has announced a €6.5 million investment at its Vizag [...]

August 6, 2025
Artificial Intelligence,Clinical Trials,Drug Development,Regulatory Affairs
Yseop on FDA’s AI push: Why structured, explainable content is the future of regulatory submissions
As the FDA accelerates its use of generative AI in [...]

May 19, 2025
Clinical Trials
Shilpa Medicare’s Nor-UDCA tablets advance in India: SEC recommends marketing authorization following positive phase 3 results
April 22, 2025

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