Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
DBV Technologies today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ lower dose version (0.15mg) of Symjepi ™ for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
This Halloween across America, teal pumpkins will signal safe treats for trick-or-treaters with food allergies as part of the Teal Pumpkin Project, an awareness initiative jointly supported this year by Food Allergy Research & Education (FARE), the Asthma and Allergy Foundation of America and several other groups.
Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey For Immediate Release September 20, 2018 Contact Consumers 214-221-1813 Announcement Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch,because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume...
Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® available through Walgreens locations nationwide. The Asthma and Allergy Foundation of America (AAFA) applauds this effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.
Walgreens and kaléo, a privately-held pharmaceutical company, are working together to improve access to epinephrine auto-injectors by making kaléo’s AUVI-Q® 0.15 mg and 0.3 mg available through Walgreens locations nationwide. This comes in an effort to help thousands of Americans with their epinephrine needs during the back to school season, as supply issues have been reported to the U.S. Food and Drug Administration (FDA) by other manufacturers.
INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.
The U.S. Food and Drug Administration today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date.
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
Kaléo, a privately-held pharmaceutical company, today commented on reports of continued manufacturing delays of epinephrine auto-injectors in the United States. Kaléo confirmed that AUVI-Q® (epinephrine injection, USP) Auto-injectors are available for prescription and are not affected by the manufacturing delays reported by other epinephrine auto-injector manufacturers. Kaléo has sufficient supply to meet any anticipated demand. For live assistance in filling an AUVI-Q prescription, any patient,
Genentech announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval.
[PRESS RELEASE] Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. We are actively exploring several options with Pfizer that would help stabilize supply.
Have you had trouble reading USDA food labels for top 8 allergens (milk, egg, peanut, tree nut, wheat, soy, fish and shellfish)? The U.S. Department of Agriculture (USDA) Food and Inspection Service regulates meat, poultry, processed egg products and certain foods that contain these products. AAFA needs your story about the challenges of reading these labels to submit to the USDA to prove the need for clearer allergen labeling for the top 8 allergens.
Have you had issues with undeclared sesame or sesame hiding in foods? We need your story to submit to the Food and Drug Administration (FDA) to prove the need for allergen labeling for sesame in the U.S. Send us your examples of the following to firstname.lastname@example.org . Foods with undeclared sesame - these are foods where a) “sesame” is not listed in the ingredients, and b) you confirmed separately that there is sesame in the product. Food labels where sesame is listed in the ingredients under an...