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The FDA issued a complete response letter to Tanvex BioPharma for its proposed biosimilar for Amgen’s Neupogen (filgrastim) for the creation of white blood cells following chemotherapy. Read More
Johnson & Johnson said it will contest a Philadelphia jury’s decision to award $8 billion to a man who claimed its drug Risperdal (risperidone) caused him to grow breasts. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for sending an email to doctors about its insomnia pill Doral (quazepam) that left out the fact that the drug is a benzodiazepine, a class-four controlled substance. Read More
NICE determined that if erenumab only works as well as botulinum toxin type A, cost-effectiveness estimates are much higher than what it considers acceptable. Read More
Public Citizen has petitioned the FDA to immediately withdraw the approval of AMAG Pharmaceutical’s preterm birth injection Makena (hydroxyprogesterone caproate) because of the failure of a post-market clinical trial. Read More