Related to Amgen’s Denosumab Cleared by FDA for Second Indication

• Genentech Takes Another Shot at Convincing FDA to Maintain Avastin’s Metastatic Breast Cancer Approval
  
• FDA Issues Novartis with CRL Requesting Additional Safety Data on Gouty Arthritis Drug
  
• Even Split on OS vs. PFS As Primary Endpoint for Cancer Drug Approvals
  
• FDA Clears Roche’s Perjeta as Combination Therapy for Metastatic Breast Cancer
  
• FDA Clears Beckman Coulter’s phi Blood Test for Prostate Cancer
  
• FDA Approves Qiagen’s KRAS Companion Diagnostic And New Use for Erbitux
  
• FDA Clears First New G-CSF Neutropenia Therapy in 10 Years
  
• Novel Treatment for Most Common Type of Lung Cancer
  
• FDA Approves Novartis' Flucelvax
  
• Exelixis Scores First FDA Approval for Thyroid Cancer Drug
  
• FDA Blocks Novo, Boosts Celgene
  
• Roche's Genentech Wins FDA OK for Breast Cancer Drug
  
• FDA Halts Amgen Sensipar Trials After Patient Dies
  
• Bayer Prostate Cancer Drug Gains FDA Approval
  
• FDA Rubber-Stamps APP Pharma’s Generic Topotecan for Small Cell Lung and Cervical Cancers
  
• FDA Approves ProStrakan’s Abstral for Breakthrough Cancer Pain
  
• FDA Clears Herceptin-Chemotherapy Combo for Metastatic Her2+ Gastric Cancer
  
• Amgen’s Xgeva Approved by EC for Treating SREs in Adults with Solid Tumor-Related Bone Metastases
  
• FDA Gives Amgen’s Prolia the Go-Ahead in Two Cancer Therapy-Induced Bone Loss Indications
  
• FDA Requests More Risk-Benefit Data for Amgen’s Xgeva sBLA in Prostate Cancer