On August 26, 2019, the FDA approved a new indication for ixekizumab (Taltz) for the treatment of adult patients with active ankylosing spondylitis. Ixekizumab has received previous FDA approval for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for the treatment of adult patients with active psoriatic arthritis.
Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
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.
Enzalutamide (Xtandi) and apalutamide (Erleada) had strong showings in 2 separate, randomized phase 3 clinical trials demonstrating that these drugs delay disease progression when added to background androgen-deprivation therapy (ADT) in patients with metastatic, hormone-sensitive prostate cancer.
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.
Darolutamide, New Androgen Receptor Inhibitor, Extends Metastasis-Free Survival in High-Risk Prostate Cancer
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.
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Results 1 - 10 of 29
Results 1 - 10 of 29