Related to FDA and EMA Take Steps to Restrict Avastin Use in Breast Cancer

• 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
  
• Roche Gets CE Clearance for Two HCV Molecular Diagnostics
  
• 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
  
• FDA Approves Tysabri Label Change and Test for JC Virus Infection in MS Patients
  
• FDA Clears Subcutaneous Velcade for All Approved Indications
  
• EC Okays Merck Serono’s Rebif for Patients With Early Stages of MS
  
• FDA Clears Leo’s Picato Gel for 2–3 Day Treatment of Actinic Keratosis
  
• FDA Clears Roche’s Erivedge for Treating Advanced Basal Cell Carcinoma
  
• Pfizer’s Inlyta Approved in U.S. as Therapy for Advanced Renal Cell Carcinoma
  
• 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