FDA News

Abbott received approval for the use of its handheld diagnostic blood test that produces results within 15 minutes and can help evaluate patients with suspected mild traumatic brain injuries, including concussions.
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The FDA approved a new intramuscular injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.
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The FDA has approved Maci, the first tissue-engineered autologous cellularized scaffold product for the repair of symptomatic cartilage in adult patients with knee defects. Maci is composed of cells grown from the patient’s own healthy cartilage tissue, which are then placed onto a bioresorbable collagen membrane and surgically implanted over the area where the damaged tissue was removed.
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  • Abuse-Deterrent Troxyca ER Approved for Chronic Pain
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Opioid analgesics are among the most often prescribed drug classes in the United States. The National Institute on Drug Abuse estimated that in 2014, US pharmacies dispensed 245 million prescriptions for opioids for the treatment of patients with acute or chronic pain.
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On April 29, 2016, the FDA approved oxycodone (Xtampza ER) extended-release (ER) capsules, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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The US Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
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The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
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  • Zinbryta a New Treatment Available for Relapsing Multiple Sclerosis
  • Nuplazid First Drug Approved for Hallucinations and Delusions Associated with Parkinson's Disease
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Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system (CNS) that causes demyelination and axonal damage in the brain, spinal cord, and optic nerves. The demyelination in MS is thought to be the result of abnormal immune response in which activated lymphocytes (T-cells and possibly B-cells) impact the CNS myelin.

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