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FDA News & Updates

  • Maci Approved for the Reparation of Cartilage Defects
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.
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.
  • Adalimumab Biosimilar FDA-Approved to Treat Multiple Indications
  • First Drug for Duchenne Muscular Dystrophy Granted Accelerated Approval
  • FDA Approves Etanercept Biosimilar for Multiple Indications
The US Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
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.
  • FDA Approves Infliximab Biosimilar for Multiple Indications
  • Ixekizumab FDA Approved for Patients with Plaque Psoriasis
  • First Once-Daily, Oral JAK Inhibitor Approved for Patients with RA
On February 9, 2016, Celltrion's infliximab biosimilar CT-P13 was recommended for approval by a vote of 21 to 3 by the US Food and Drug Administration's (FDA) Arthritis Advisory Committee.
The US Food and Drug Administration (FDA) has approved lesinurad (Zurampic; AstraZeneca Pharmaceuticals LP, Wilmington, DE) for use in combination with a xanthine oxidase inhibitor (XOI), which is approved for reducing the production of uric acid in the body, in patients with gout-associated hyperuricemia.
The US Food and Drug Administration (FDA) has issued draft guidance for the naming of biosimilars. The FDA proposal calls for attachment of 4-letter suffixes to distinguish a biosimilar from the originator product and biosimilars from other biosimilars.
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  • Rheumatology Practice Management
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  • American Health & Drug Benefits
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