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FDA Adds Boxed Warning to Montelukast Over Mental Health Risks

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The US Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair), which is used to treat asthma and allergy. The agency will add a boxed warning to montelukast advising healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, according…

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Japan Confirms First Case of Infection With New China Coronavirus

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TOKYO – Japan confirmed the first case of infection from the new China coronavirus that has killed one person and prompted a travel alert from the U.S. State Department. A man in his 30s from Kanagawa prefecture, next to Tokyo, tested positive, Japan’s health ministry said in a statement on Thursday. The man had been…

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FDA Clears Next-Gen Assay to Detect HIV-1 Drug Resistance Mutations

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The US Food and Drug Administration (FDA) has approved the Sentosa SQ HIV genotyping assay (Vela Diagnostics USA Inc) that uses next generation sequencing technology to detect HIV-1 drug resistance mutations from a blood sample. Recent data suggest that the percentage of people living with HIV around the world that have resistance to some HIV drugs has…

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Protecting yourself during cancer treatment

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Experts recommend that patients protect themselves from infection by taking certain precautions, many of which may make for some socially awkward moments, like declining a handshake at a business meeting. But there are ways to manage both your health and your social relationships, and it often starts with a healthy dose of information. With a…

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US, Canada, Australia Simultaneously Approve Endometrial Cancer Combo

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The US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada (HC) today simultaneously approved a new two-drug combination for the treatment of advanced endometrial carcinoma. The three agencies worked together under the umbrella of Project Orbis, a new FDA initiative that allows concurrent submission and review of oncology products among…

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