DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company’s Biologics License Application (BLA) for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
Many people are concerned about the food you can’t see – the food left on restaurant tables, school cafeteria tables and in the home kitchen . It’s a valid concern. Some cleaning methods don’t completely remove food allergens. A person with a food allergy may be at risk of having a serious allergic reaction (anaphylaxis) from cross-contact if they eat their food off that surface. The Food and Drug Administration (FDA) has done a study called “ Allergen Removal and Transfer Using Wiping and...
Question: If you haven’t eaten a food in a couple of years and then try it again, does that increase your chances of developing an allergy to that food? Is it possible for a first allergic reaction to a food to be anaphylaxis? (Anaphylaxis is a severe allergic reaction that can be life-threatening.)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints. Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase 3 trial.
If you have received Amneal or Impax’s 0.3mg epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by following the instructions below. You can find photos to explain the steps in the letter sent to consumers . Epinephrine is a life-saving medicine for people with severe allergies. There are different devices available in the U.S. and each device has its own unique set of instructions.
Epinephrine is a lifesaving medicine for people with severe allergies. It is important to discuss with your doctor about what is the most appropriate prescription for your family. You may also need to find out which options your insurance provider prefers. This will affect your out-of-pocket costs.
May is National Asthma and Allergy Awareness Month . May 10-16, 2020, is Food Allergy Awareness Week. The Asthma and Allergy Foundation of America (AAFA) and MedicAlert have teamed up to help you manage your child’s food allergies and prevent severe allergic reactions. (Kids With Food Allergies is a division of AAFA). We’re asking you to “ACT” to manage your child’s allergies: “A” means have an action plan for anaphylaxis. “C” reminds you to carry important medicines and have your child wear...
May is National Asthma and Allergy Awareness Month . May 10-16, 2020, is Food Allergy Awareness Week. The Asthma and Allergy Foundation of America (AAFA) and MedicAlert have teamed up to help you manage your child’s food allergies and prevent severe allergic reactions. (Kids With Food Allergies is a division of AAFA). We’re asking you to “ACT” to manage your child’s allergies: “A” means have an action plan for anaphylaxis. “C” reminds you to carry important medicines and have your child wear...
The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperature
FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to device failure and user error.
The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).
On Jan. 31, 2020, the U.S. Food and Drug Administration (FDA) announced its approval of Aimmune Therapeutics’ peanut treatment, Palforzia, for children ages 4 to 17. This is big news for the food allergy community. Food allergies put a significant mental, social and financial burden on families. Until now, strict avoidance has been the only way to avoid allergic reactions. Palforzia may give many families managing peanut allergies more freedom and greater quality of life.
DBV Technologies, a clinical-stage biopharmaceutical company, today announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure.
On Dec. 16, 2019, Congress released a spending package to keep the government funded for 2020. This plan includes two big wins for food allergy research.
Congratulations to New York and the family of Giovanni Cipriano on the passing of Gio's Law. Gio's Law, S3247B, authorizes certain New York emergency service providers to be trained to treat anaphylaxis, a serious allergic reaction, and carry epinephrine in their vehicles.