Related to FDA Fails to Back Janssen, Bayer’s Xarelto for Acute Coronary Syndrome

• 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 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
  
• 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
  
• Readers Show Confidence in FDA’s Biosimilar User Fee Framework
  
• FDA Clears BTG’s Voraxaze for Treating Methotrexate Toxicity
  
• Gilead Wins Sanction in the U.S. for Viread in HIV-Infected Children
  
• FDA Asks BMS, AstraZeneca for More Clinical Data for Antidiabetic