FDA Approves New Combination HIV Drug
November 18th 2018The FDA has approved lamivudine and tenofovir disoproxil fumarate (Temixys, Celltrion) tablets, 300 mg/300 mg in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
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Eltrombopag Granted FDA Approval for Severe Aplastic Anemia
November 18th 2018he FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia.
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FDA OKs Rifamycin for Travelers' Diarrhea Caused by Noninvasive E coli
November 17th 2018Rifamycin's effectiveness was shown in a randomized, placebo-controlled clinical trial during which the drug significantly reduced symptoms of travelers’ diarrhea in adults afflicted with the condition in Guatemala and Mexico.
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FDA Approves Adcetris with Chemo for First-Line Peripheral T-Cell Lymphoma Treatment
November 17th 2018The FDA has expanded the approved use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma.
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First-line Treatment for PTCL Granted FDA Approval Under New Review Pilot
November 17th 2018The FDA has expanded the approved use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL).
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FDA Panel Recommends Abuse-Deterrent Oxycodone Tablets
November 16th 2018The Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse, but they voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.
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