• Safety & Recalls
  • Regulatory Updates
  • Drug Coverage
  • COPD
  • Cardiovascular
  • Obstetrics-Gynecology & Women's Health
  • Ophthalmology
  • Clinical Pharmacology
  • Pediatrics
  • Urology
  • Pharmacy
  • Idiopathic Pulmonary Fibrosis
  • Diabetes and Endocrinology
  • Allergy, Immunology, and ENT
  • Musculoskeletal/Rheumatology
  • Respiratory
  • Psychiatry and Behavioral Health
  • Dermatology
  • Oncology

FDA Pipeline Preview, October 2011 (Janssen Biotech, GlaxoSmithKline, Pfizer, Johnson & Johnson, Bayer AG, ApoPharma, BTG, Chelsea Therapeutics, QLT, Neuraltus Pharmaceuticals, Accentia, 4SC, Tarix Pharmaceuticals)


Recent FDA action (through September 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001, cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127

Complete response

Recommendations for approval

Fast-track designations

Orphan drug designations

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