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FDA approves first anticoagulant for pediatric patients to treat potentially life-threatening blood clots

The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.

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Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

The U.S. Food and Drug Administration approved a treatment using Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia.

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FDA Approves Bavencio Plus Inlyta Combination for Patients with Advanced Renal Cell Carcinoma

EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.

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FDA Approves Eylea for Diabetic Retinopathy

The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.

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FDA Approves Zebra Medical’s AI Chest X-Ray Product

Israel’s Zebra Medical Vision received approval from the U.S. Food and Drug Administration for the company’s artificial intelligence-based chest X-ray triage product.

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Waylivra Approved In EU For Treating FCS

Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.

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Pfizer gets U.S. approval for $225,000 a year heart drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.

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Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions

The U.S. FDA gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine can cause severe infections in some people.

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AbbVie’s Mavyret Approved for Hep C in Pediatric and Adolescent Patients

The U.S. FDA approved AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older during 2017.

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FDA approves expanded label for Praluent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

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