Tag: Food and Drug Administration (FDA)

Aravax

Aravax Doses First Patient in Phase 2 Peanut Allergy Clinical Trial 

PVX108 does not contain peanut proteins which put patients at risk of serious side effects.
FDA Draft Guidance

FDA Issues New Draft Guidance Regarding Allergen Labeling and Cross-Contact

Spoiler Alert: the draft does nothing to help the food allergy community.
neffy®

FDA Panel Supports Approval of neffy® Epinephrine Nasal Spray

The first needle-free emergency epinephrine alternative is on the verge of FDA approval.
Bryn Pharma Intranasal Epinephrine Device

Bryn Pharma Raises Another $15 Million for Commercialization of Needle-Free Intranasal...

Company is developing UTULY for intranasal emergency epinephrine delivery.
Viaskin Peanut

DBV Outlines Path to Regulatory Approval of Viaskin Peanut Patch

Are Viaskin therapies finally on the horizon?
neffy FDA Advisory Committee

Hoping Needle-Free Intranasal Epinephrine will be Approved? Tell the FDA!

Your testimony is important and there are two ways you can participate.
neffy®

FDA Schedules Review of neffy®, an Intranasal Alternative to Epinephrine Auto-Injectors

Meeting signals the FDA believes neffy has potential for approval given data gleaned from clinical trials.
Skin Prick Testing

FDA Issues Warning After Patients Receiving Negative Skin Prick Results Later...

Important information regarding skin prick testing for food allergies.
Russell Stover Heart

One Example of Confusing (and Legal) Allergen Labeling at Your Local...

Help us change ambiguous regulations!
Hilary Duff and Scallops

Hilary Duff Finds She is Allergic to Scallops — But Are...

A shout out to Hilary and a quick lesson in allergen labeling.