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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Treatment With Ravulizumab-cwvz Shows Long-Term Improvements in Generalized Myasthenia Gravis
April 13th 2022Ravulizumab-cwvz (Ultomiris) produced statistically significant improvements in measures of functional activity, muscle strength, and quality of life in patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.
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