The makers of the epinephrine nasal spray called neffy are pushing forward in the effort to win approval from the… Read more »
Tag: FDA
Neffy CEO: Why FDA Rejection of Epi Nasal Spray Was a Shocker
This fall, ARS Pharma’s epinephrine nasal spray seemed like a sure bet to win Food and Drug Administration approval. In… Read more »
FDA Advice to Cut Food Allergy Label Errors: What Will It Change?
The FDA has issued new advice to food manufacturers on cross-contact and accurate labeling for top food allergens. This draft… Read more »
Setback for Neffy Epinephrine Spray as FDA Calls for More Study
The U.S. Food and Drug Administration has declined to approve a novel epinephrine nasal spray to treat allergic reactions. Instead,… Read more »
‘Call to Action’ After Allergy Skin Test Extracts Give False Results
A team of allergists is urging improved standardization of allergen extracts used in allergy skin testing after studying peanut extracts… Read more »
FDA Delays Decision on Neffy Epinephrine Spray Until September
The U.S. FDA has extended the date to complete its review of the neffy nasal epinephrine spray until September 2023. … Read more »
Viaskin Peanut Patch Desensitized Most Toddlers in Phase 3 Trial
The Viaskin patch for peanut allergy is showing promise in desensitizing peanut-allergic toddlers in a late-stage trial. After wearing the… Read more »
FDA Criticized for Response to Bakers Adding Sesame Allergen
A bakers’ group is citing “consumer safety” as the reason for the sudden addition of sesame – now the ninth… Read more »
Publix Labels: Protecting or Deterring Allergy Shoppers?
Meredith Smith was surprised to find allergen warning labels on fresh meat and seafood recently at Publix supermarkets in Florida.… Read more »
Q&A: Dupilumab Approved for EoE, Plus Hope for More Therapies
The U.S. Food and Drug Administration approved dupilumab for eosinophilic esophagitis in patients 12 and up in May 2022. This… Read more »