The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.
Category Archives: Food Safety News
Fairway ‘‘Like No Other Market’’ ® Recalls Fairway Brand Cookies Blondie Because Of Possible Health Risk
Fairway ‘‘Like No Other Market’’® of New York, NY is voluntarily recalling Fairway brand Cookies Blondie, because the product may contain undeclared ingredient, walnuts. People who have an allergy or severe sensitivity to nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA approves treatment for chronic graft versus host disease
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia
The U.S. Food and Drug Administration today 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.
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year
roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction,
at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to
efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate
balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also
providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.
The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
FDA clears first neonatal magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation
More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today 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 been previously treated with a regimen that includes the drug trastuzumab.
Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk
Grand Priarie, TX, Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). New of Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk.
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