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Axicabtagene Ciloleucel (Yescarta) gene therapy for diffuse large B-cell lymphoma

October 19, 2017 – The American  Food & Drug Administration (FDA) just approved Axicabtagene Ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

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Brodalumab (Siliq) with a fatal touch: New psoriasis drug approved

February 16, 2017 – The American Food & Drug Administration (FDA) just approved Brodalumab (Siliq) to treat adults with moderate-to-severe plaque psoriasis. Brodalumab (Siliq) is administered as an injection. Brodalumab (Siliq) is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream,

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The weight-management drug Liraglutide (Saxenda) has just been approved by the FDA

December 23, 2014 – The U.S. Food and Drug Administration (FDA) just approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension,

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Dulaglutide [Trulicity], a glucagon-like peptide-1 (GLP-1) receptor agonist, approved for the treatment of type 2 diabetes

September 18, 2014 – We learn today from the U.S. Food and Drug Administration (FDA) of the approval of  Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

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US: Approval of Alglucosidase Alfa [Lumizyme] to treat Pompe disease expanded to patients of all ages

August 1. 2014 – The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition,

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FDA approves Albiglutide [Tanzeum] to treat type 2 diabetes

April 16, 2014 – The U.S. Food and Drug Administration (FDA)  yesterday  approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States.

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Belatacept [Nulojix]: Increased Risk of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML)

July 7, 2011 – Bristol-Myers Squibb (BMS) today informed healthcare professionals about a REMS (Risk Evaluation and Mitigation Strategy) that is required for Belatacept [Nulojix] to ensure that the benefits of Belatacept [Nulojix] outweigh the risks of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal.

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