FDA Approves New Indication for Rituximab Biosimilar for Rheumatoid Arthritis
June 7th 2022In addition to the new approval for rheumatoid arthritis, Riabni has already been approved for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
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Enhertu Lowers Risk of Disease Progression, Death by 50% in HER2-Low Metastatic Breast Cancer
June 5th 2022Trastuzumab deruxtecan shows superior and clinically meaningful progression-free survival and overall survival benefit in patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor-positive or negative disease.
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Brentuximab Vedotin Combo Lowers Risk of Death in Patients With Hodgkin Lymphoma
June 4th 2022Brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine shows improved overall survival compared with standard chemotherapy in patients with previously untreated, advanced stage classical Hodgkin lymphoma.
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FDA Grants Breakthrough Therapy Designation to Repotrectinib for ROS1-Positive Metastatic NSCLC
May 12th 2022Repotrectinib awarded breakthrough therapy designation for patients with ROS1-positive metastatic non–small cell lung cancer previously treated with a ROS1 tyrosine kinase inhibitor and who were not previously administered platinum-based chemotherapy.
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FDA Approves Baricitinib for Certain Adult Patients Hospitalized With COVID-19
May 11th 2022Baricitinib (Olumiant) approved for the treatment of adult patients hospitalized with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
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FDA Limits Use of Johnson & Johnson COVID-19 Vaccine Due to Risk of Rare Blood Clots
May 6th 2022FDA action was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome, a rare and potentially life-threatening condition that causes blood clots combined with low levels of blood platelets.
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FDA Approves Trastuzumab Deruxtecan for Certain Patients With HER2-Positive Metastatic Breast Cancer
May 5th 2022Trastuzumab deruxtecan (Enhertu) approved for adult patients with unresectable or metastatic HER2-positive breast cancer who were previously administered an anti–HER2-based regimen.
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Darolutamide/Docetaxel Granted FDA Priority Review for Metastatic Hormone-Sensitive Prostate Cancer
May 4th 2022Trials results show darolutamide, docetaxel, and androgen deprivation therapy (ADT) reduced the risk of death by 32.5% versus docetaxel/ADT in patients with metastatic hormone-sensitive prostate cancer.
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FDA Approves Upadacitinib for Active Ankylosing Spondylitis
May 2nd 2022FDA approves 15 mg upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active ankylosing spondylitis who previously showed an inadequate response or intolerance to 1 or more tumor necrosis factor inhibitors.
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FDA Approves Osteseconazole for Recurrent Vulvovaginal Candidiasis
May 2nd 2022Osteseconazole (Vivjoa) is the first FDA-approved treatment for recurrent vulvovaginal candidiasis, also known as chronic yeast infection, in women with a history of the condition who are not of reproductive potential.
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