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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