AstraZeneca and its partner Amgen Inc. (Amgen) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, is pleased to announce that Aetna, one of the largest health insurance companies in the United States, has updated its Exhaled Breath Tests Clinical Policy to include the measurement of exhaled nitric oxide as “medically necessary” for the evaluation of asthma and for monitoring the response to long-term control therapy.
One recent food trend has some people concerned: adding liquid nitrogen right before eating to create the effect of smoke. It may sound fun, but is it safe, especially for people with asthma?
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.
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.
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.
Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.
Genentech, a member of the Roche Group, today announced that the Phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.
If you’ve never suffered from eczema, also known as atopic dermatitis, you probably aren’t aware of the negative impact it can have on quality of life. The severe itching, redness and excessively dry skin all make life miserable for those who suffer from the allergic disease.
Although about 10 percent of school-aged children in the United States have asthma, there are few comprehensive U.S. guidelines for treating pediatric asthma. The Pediatric Asthma Yardstick, a new guideline from the American College of Allergy, Asthma and Immunology (ACAAI), offers a user-friendly “operational document”. It helps health care professionals understand which controller treatments are right for which age groups and identifies when a step up is needed.
Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles
The Asthma and Allergy Foundation of America is sharing this press release from GlaxoSmithKline to bring you the latest research news quickly. [PRESS RELEASE] Nucala (mepolizumab) study reports long-term safety data, consistent exacerbation reduction and improved asthma control New study showed one third of patients had no exacerbations on long-term treatment with Nucala GlaxoSmithKline plc (GSK) today presented new data from the longest study of an anti-IL5 biologic treatment in severe...
When Joey was 4 years old, his parents took him to see an allergist. He was having trouble breathing and having challenges with his digestive system. They learned that Joey has asthma triggered by environmental and food allergies.
As Nancy Gomez knows, managing a child’s severe asthma can take a big toll on a parent’s time, finances and emotions. Nancy’s 10-year-old son, Oziel, has had asthma and allergies since he was a baby. Today Oziel has environmental allergies to pollen, animals, dust, smoke and more. His allergies, exercise and cold weather all trigger his asthma. On top of this, Oziel also has life-threatening food allergies. And he is autistic. Managing all of this is a constant challenge.