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FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia
Written by Aaron Watson on 2017-08-17


The U.S. Food and Drug Administration has approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML."Idhifa is a targeted therapy that...(Read More)

FDA approves Vosevi for Hepatitis C

FDA approves Vosevi for Hepatitis C
Written by Aaron Watson on 2017-08-08


The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs - sofosbuvir and velpatasvir - and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously...(Read More)

FDA approves new treatment to reduce the risk of breast cancer returning

FDA approves new treatment to reduce the risk of breast cancer returning
Written by Aaron Watson on 2017-08-02


The U.S. Food and Drug Administration has approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have...(Read More)

FDA approves new treatment for sickle cell disease

FDA approves new treatment for sickle cell disease
Written by Aaron Watson on 2017-07-25


The U.S. Food and Drug Administration has approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. "Endari is the first treatment approved for patients with sickle cell disease in almost 20 years," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products...(Read More)

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
Written by Aaron Watson on 2017-07-19


The U.S. Food and Drug Administration has cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors."We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,"...(Read More)

Cosmetic complaints climb but products still on market

Cosmetic complaints climb but products still on market
Written by Aaron Watson on 2017-07-13


Many cosmetic products entice consumers with active ingredients that will plump, lengthen and boost.But the cost, depending on the product, may be serious injury or worse, according to a new Northwestern Medicine study.The study reports consumer complaints more than doubled for cosmetic products from 2015 to 2016, with hair care products being the biggest offender. But consumers remain at risk because...(Read More)

New study exposes major flaws in US drugs with

New study exposes major flaws in US drugs with 'accelerated' approval
Written by Aaron Watson on 2017-07-07


A new study has exposed major flaws in the fast tracking of some drugs available to the American public without any stringent clinical evidence of their benefits.Researchers from the London School of Economics and Political Science (LSE) and the United States say that many US patients with serious illnesses are being treated by drugs which have questionable data.The findings, published in The Milbank...(Read More)

FDA approves first generic Strattera for the treatment of ADHD

FDA approves first generic Strattera for the treatment of ADHD
Written by Aaron Watson on 2017-07-01


The U.S. Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited has gained approval to market atomoxetine in multiple strengths."Today's approvals mark an important...(Read More)

Nearly 1 in 3 drugs found to have safety concerns after FDA approval

Nearly 1 in 3 drugs found to have safety concerns after FDA approval
Written by Aaron Watson on 2017-06-04


How often are safety concerns raised about a drug after it's been approved by the FDA? Nicholas Downing, MD, of the Department of Medicine at Brigham and Women's Hospital, and colleagues have found that for drugs approved between 2001 and 2010, nearly 1 in 3 had a postmarket safety event. The team defines postmarket safety events as those that lead to either withdrawal from the market due to safety...(Read More)





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