Blog Archives

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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  • In-office gene therapy for wet age-related macular degeneration is coming October 11, 2019
    Gene therapy is showing promise for one of the most common causes of blindness. Data presented today shows that six patients with wet age-related macular degeneration (AMD) have, so far, gone at least six months without the need for continued injections to control a disease that typically requires treatment every four to six weeks. Researchers […]
  • Powerful new genomics method can be used to reveal the causes of rare genetic diseases October 11, 2019
    A team led by a scientist at Scripps Research has invented a new genomics technique for tracking down the causes of rare genetic diseases.
  • Jumping genes can cause rare developmental disorders in children October 11, 2019
    The largest study of its kind into childhood developmental disorders has discovered that jumping genes cause genetic changes in some patients with undiagnosed neurodevelopmental diseases. The research from the Wellcome Sanger Institute and its collaborators in the NHS Regional Genetics services enabled genetic diagnoses for three children with previously undiagnosed rare developmental diseases who were […]
  • New customized drug treatment bypasses a single child's unique mutation within a year of diagnosis October 10, 2019
    An unprecedented case at Boston Children's Hospital shows that it's possible to do something that's never been done before: identify a patient's unique mutation, design a customized drug to bypass it, manufacture and test the drug, and obtain permission from the Food and Drug Administration (FDA) to begin treating the patient—all in less than one […]
  • Multigene testing for all breast cancer patients cost-effective October 10, 2019
    (HealthDay)—Unselected, multigene testing for all patients with breast cancer would be cost-effective in the United Kingdom and the United States, according to a study published online Oct. 3 in JAMA Oncology.
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