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JAK Inhibitors Implement FDA Class Warning
[443 Words]
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| An FDA-ordered drug class warning begins appearing in labels of Janus kinase (JAK) inhibitors — Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib). |
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12/06/2021
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RefleXion Breakthrough for Radiotherapy
[145 Words]
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| FDA grants RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors. |
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12/06/2021
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Keytruda Gets Approval for Certain Melanoma Patients
[152 Words]
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| FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage 2B or 2C melanoma following complete resection. |
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12/06/2021
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FDA OKs Rituxan plus Chemo for Pediatric Lymphoma
[211 Words]
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| FDA approves Genentech’s Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. |
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12/06/2021
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FDA Reviewers Doubt Reata Kidney Drug’s Effectiveness
[280 Words]
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| Ahead of a 12/8 FDA advisory committee meeting, agency reviewers cast doubt on the effectiveness of Reata Pharmaceuticals’ bardoxolone to slow the loss of kidney function in Alport syndrome patients and reduce the risk of kidney failure with chronic use. |
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12/06/2021
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Theratechnologies sBLA for HIV Drug Administration
[251 Words]
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| Theratechnologies files a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous push form of administration for treating HIV-1 in combination with other antiretrovirals. |
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12/06/2021
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Members Sought for Mammography Panel
[47 Words]
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| Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. |
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12/03/2021
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Trunk/Limb Electrical Stimulator in Class 2
[113 Words]
[ Price : $8.95]
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| Federal Register notice: FDA classifies the trunk and limb electrical stimulator to treat headache into Class 2. (special controls). |
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12/03/2021
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Lilly EUA for Monoclonal Antibodies Expanded
[106 Words]
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| FDA revises an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously authorized for treating Covid-19. |
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12/03/2021
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