Related to FDA Sanctions Vertex’ Kalydeco for Treating Cystic Fibrosis Caused by G551D Mutations

• FDA Clears Alexion’s Soliris for All Patients with Atypical Hemolytic Uremic Syndrome
  
• FDA Clears Lilly’s Cialis for Treating Symptoms of BPH in Men with or without Erectile Dysfunction
  
• BioHelix’ IsoAmp Near-Patient HSV Diagnostic Gets FDA 510(k) Clearance
  
• FDA Regulations Can Do as Much Harm as Good, According to GEN Poll
  
• FDA Clears Gen-Probe’s mRNA-Based HPV Assay for Use Alongside Pap Tests
  
• FDA Green-Lights Janssen's Anticoagulant for Reducing Stroke/Embolism in Nonvalvular AF Patients
  
• FDA Lifts Hold on Start of Helix’ Trial for Topical Treatment for Cervical Lesions
  
• FDA Sanctions NYBC’s Cord Blood Hematopoietic Progenitor Cells for Transplantation
  
• FDA Sanctions Incyte’s Jakafi for Treating Myelofibrosis
  
• FDA Clears EUSA’s Asparaginase Therapy Erwinaze for Acute Lymphoblastic Leukemia
  
• FDA Revokes Avastin Indication for Treatment of Metastatic Breast Cancer
  
• FDA Clears Abbott’s Confirmatory Chagas Disease Assay
  
• FDA Okays Regeneron’s Wet AMD Therapy
  
• Nearly Two-to-One Majority Sees FDA or EMA Approval of Gene Therapy by 2013
  
• FDA Clears Hologic’s Automated Platform for Cervical Cancer Cervista HPV Assay
  
• FDA Clears Takeda’s Combination Blood Pressure Pill Edarbyclor
  
• FDA Sanctions Merck & Co.’s Isentress for Use in HIV-1 Children, Teens
  
• Perrigo’s Generic Clarinex Gets U.S. Okay
  
• FDA Approves Mylan’s First-to-File ANDAs for Hypertension, Epilepsy Drugs
  
• Even Split on OS vs. PFS As Primary Endpoint for Cancer Drug Approvals