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.
All posts by admin
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.
Read The Complete Story!
Texas Legend Foods Issues Allergy Alert on Undeclared Cheese, Milk & Egg in "Silver Star Chipotle Dip"
Texas Legend Foods of Austin, TX, is recalling its 16 ounce jars of Silver Star Chipotle Queso Dip because they contain undeclared cheese, milk and eggs. People who have allergies to cheese, milk and eggs run the risk of a serious or life-threatening allergic reaction if they consume this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse
In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.
Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests
On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.
Sunneen Health Foods Issues Recall of Parfait Due to Undeclared Allergens
Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market PB&J parfaits sold at five Whole Foods Market stores in New York and New Jersey because the products contained soy and tree nut (almond and coconut) allergens that were not listed on the product label. People who have an allergy or severe sensitivity to soy or tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids
lorida- Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.
Biohealth Nutrition Announces the Recall of Precision Blend Cookies and Cream Product for Undeclared Allergen
Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because
product labels failed to declare the food allergen, wheat. People who have an allergy or severe sensitivity to wheat run the risk of a life threatening
allergic reaction, anaphylaxis, that requires immediate medical attention should they consume
products containing allergens.
Coborn’s, Inc. Issues Recall of Incorrectly Labeled Gluten Free Chocolate Chip Bars Due To Undeclared Milk
Coborn’s, Inc. of St. Cloud, Minn. is recalling packages of its Gluten Free Chocolate Chip Bars, some of which were incorrectly labeled as Gluten Free Fudge Brownies. The Gluten Free Fudge Brownie label does not indicate the product contains milk, however the Gluten Free Chocolate Chip Bars that are incorrectly labeled as Gluten Free Fudge Brownies do contain milk.
FDA approves new treatment for sickle cell disease
The U.S. Food and Drug Administration today 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.