Related to 2-to-1 Majority of Respondents to a GEN Poll See Smooth Sailing Ahead for Vivus' Obesity Therapy

• FDA Sanctions Vertex’ Kalydeco for Treating Cystic Fibrosis Caused by G551D Mutations
  
• FDA Approves Label Change Recommending Three Years of Novartis' Glivec After GIST Surgery
  
• Roche’s Cobas Test for Chlamydia and Gonorrhea Granted 510(k) Clearance in U.S.
  
• FDA Okays Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults
  
• FDA Issues Draft Guidance for Getting Biosimilars Approved
  
• FDA Clears Gen-Probe’s PCA3 Urine Assay for Predicting Need for Repeat Prostate Biopsies
  
• BioSante, Teva Win FDA Nod for Male Hypogonadism Therapy
  
• FDA Clears MedImmune’s FluMist Quadrivalent Flu Vaccine
  
• FDA Clears Discovery Laboratories’ Drug for Respiratory Distress Syndrome in Infants
  
• FDA Approves Organogenesis’ Gintuit Cell-Based Product for Gum Disease
  
• FDA Clears Affymax and Takeda’s Once-Monthly ESA for Anemic CKD Patients on Dialysis
  
• FDA Clears Avid’s Amyloid Plaque Imaging Agent for Aiding Alzheimer Disease Diagnosis
  
• FDA Clears Qiagen’s Rotor-Gene MDx RT-PCR IVD Platform and Influenza Assay
  
• FDA Clears Leica’s Her2 Immunohistochemical Assay on Bond-Max Instrument
  
• Takeda’s Type 2 Diabetes Therapies Set Back Again by FDA
  
• 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
  
• GSK’s Votrient Approved in U.S. for Treating Soft Tissue Sarcoma
  
• Protalix, Pfizer Report FDA Approval of Plant-Derived Gaucher Disease ERT Elelyso
  
• Genzyme Gets FDA, EMA Approvals for Production Plant in Waterford, Ireland