Tag: Food and Drug Administration (FDA)

Wilton Bunny Hutch Kit

Easter Kit Recall Exposes Serious Ambiguity in US Allergen Labeling Regulations

The problem underlying the recall is not as clear-cut as stated on the FDA's website.

Public Health Organization Calls for Allergen Thresholds to Guide Product Labeling

Acceptable thresholds for allergen trace would make labeling safer and more reliable for the food allergy community.
Nuts

Nuts! What They Really Are and How the FDA Classifies Them...

Deciphering the FDA's "tree nut" designation can be confusing. Here's a quick primer to help.
Aquestive AQST-108 Epinephrine Film

Sublingual Epinephrine for Anaphylaxis Receives Fast Track Designation from FDA

AQST-109 is the first orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions including anaphylaxis.
Skin Prick Testing

Study Finds Majority Learn of Their Sesame Allergy After Diagnosis of...

Only 1/3 of patients had prior reaction to sesame.
Test Tubes

FDA Green Lights Phase 2 Trials of PVX108, a Novel Peptide-Driven...

Phase 2 study of candidate from Aravax will commence in the US and Australia.
Aquestive's Subingual Epinephrine

Aquestive’s Sublingual Epinephrine Achieves Therapeutic Blood Concentrations Following Administration

Company presented top level Phase 1 results at #AAAAI2022 meeting.
Moonlight Therapeutics Microneedle Patch

Study Finds Microneedle Delivery Successful in Test of Peanut Allergy Immunotherapy

Study finds five-minute weekly dose of peanut protein through the skin, delivered by a novel microneedle technology, was superior in desensitizing peanut-allergic mice compared to administering the protein through a skin patch.
Claire Rowan and Son

Desperate Virginia Mom Turned to Internet for Help When Her Allergic...

Community rallies in support of mom whose son relies on a feeding tube.