FDA Approvals, News & Updates
On August 16, 2019, the FDA approved upadacitinib (Rinvoq, AbbVie), a Janus kinase inhibitor, for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
On July 24, 2019, the US Food and Drug Administration approved adalimumab-bwwd (Hadlima; Samsung Bioepis), a biosimilar to adalimumab (Humira; AbbVie) for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
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.
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). This is the latest in a number of steps recently outlined by the FDA in their bid to reassess their approach to opioid medications.
Ixekizumab (Taltz) has been approved by the US Food and Drug Administration (FDA) for use in patients with moderate-to-severe plaque psoriasis, the agency has announced. Administered as an injection, ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein.
The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
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Results 1 - 10 of 12