FDA Approves Carnexiv Injection as Short-Term Replacement Treatment for Oral Carbamazepine
October 20th 2016The FDA has approved Lundbeck's Carnexiv, also known as carbamazepine, as a short-term (≤7 days) intravenous replacement treatment for adults with certain seizure types who cannot take the oral form of carbamazepine.
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FDA Approves Expanded Use for Biologic Autoinflammatory Disease Drug
October 17th 2016Ilaris is the first FDA-approved biologic treatment for Tumor Necrosis Factor–Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency and Familial Mediterranean Fever.
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FDA Approves New Continuous Glucose Monitoring System for Diabetes
October 7th 2016The FDA has approved a new continuous glucose monitoring (CGM) system designed to provide health care professionals with clear, visual snapshots of glucose levels, trends, and patterns in patients with diabetes at a lower cost than other CGM devices on the market.
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Stelara Biologic Approved for Crohn's Disease
October 4th 2016The FDA recently approved Janssen's ustekinumab (Stelara) for the treatment of moderate to severe active Crohn's disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, as well as those who failed or were intolerant to treatment with one or more TNF blockers.
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Tresiba Label Seeks Hypoglycemia Trial Data Inclusion
September 28th 2016Novo Nordisk has submitted a supplemental application to the FDA to include data from the 2 phase 3b SWITCH trials in the prescribing information for insulin degludec (Tresiba), a once-daily basal insulin that provides a duration of action beyond 42 hours for patients with type 1 and type 2 diabetes.
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Nintedanib Receives Orphan Drug Designation for Systemic Sclerosis
September 27th 2016The FDA has granted Orphan Drug Designation to Boehringer Ingelheim's nintedanib for the treatment of systemic sclerosis (SSc), also known as scleroderma, including associated interstitial lung disease (SSc-ILD).
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