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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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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The US Food and Drug Administration (FDA) has issued draft guidance for the naming of biosimilars.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.
Patients with chronic painful osteoarthritis (OA) may have a new pain killer if phase 3 clinical trials turn out to be positive. The drug in question, called tanezumab, has had a checkered history. At first, several trials showed that it was remarkably effective in people with OA, allowing them to resume activities they had not been able to participate in.
The US Food and Drug Administration (FDA) is hoping that its December 4, 2014, final rule on pregnancy and breastfeeding labeling for prescription drugs and biological products will be helpful to patients and providers.
On January 21, 2015, the US Food and Drug Administration (FDA) approved secukinumab (Cosentyx; Novartis Pharmaceuticals Corporation) for the treatment of adults who have moderate to severe plaque psoriasis and who are candidates for systemic therapy and/or phototherapy.
The first generic versions of Celebrex (celecoxib) capsules, a treatment for patients with rheumatoid arthritis, osteoarthritis, acute pain, and other conditions, have been approved by the FDA, according to a press release by the agency.
The US Food and Drug Administration approved the use of apremilast (Otezla), a phosphodiesterase-4 inhibitor, on March 21, 2014, for the treatment of adults with active psoriatic arthritis.
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