Related to FDA Issues Novartis with CRL Requesting Additional Safety Data on Gouty Arthritis Drug

• FDA Clears Herceptin-Chemotherapy Combo for Metastatic Her2+ Gastric Cancer
  
• Novartis’ Afinitor Cleared by FDA for Treating SEGA Tumors in Tuberous Sclerosis
  
• Amgen’s Denosumab Cleared by FDA for Second Indication
  
• Novartis Withdraws U.S. and EU sNDAs for Zometa in Breast Cancer
  
• FDA Clears Novartis’ Amturnide Triple Combination Hypertension Drug
  
• Novartis Gets FDA Okay for Meningococcal Vaccine for Children Aged 2–10 Years
  
• FDA Rubber-Stamps Bristol-Myers Squibb’s Melanoma mAb
  
• FDA Clears Novartis’ Afinitor for Treating Advanced Pancreatic NET
  
• EC Approves Roche’s RoActemra for Treating Active Systemic Juvenile Idiopathic Arthritis
  
• Genentech Takes Another Shot at Convincing FDA to Maintain Avastin’s Metastatic Breast Cancer Approval
  
• FDA Gives Amgen’s Prolia the Go-Ahead in Two Cancer Therapy-Induced Bone Loss Indications
  
• FDA Approves Label Change Recommending Three Years of Novartis' Glivec After GIST Surgery
  
• FDA Requests More Risk-Benefit Data for Amgen’s Xgeva sBLA in Prostate Cancer
  
• Novartis’ Afinitor Gets FDA Okay for Treating Renal Angiomyolipoma Associated with TSC
  
• Phase III Data Shows Novartis’ Canakinumab Enables SJIA Patients to Remain Symptom Free
  
• FDA Clears Roche’s Perjeta as Combination Therapy for Metastatic Breast Cancer
  
• FDA Approves Novartis' Flucelvax
  
• FDA OKs Novartis' Drug for Childhood Arthritis
  
• Novartis' Canakinumab Shows Benefits in Two Phase III Gouty Arthritis Studies
  
• FDA Committee Votes Against Green-Lighting Novartis’ Gouty Arthritis sBLA