Tag: FDA Fast Track Designation

Aquestive AQST-109 Epinephrine Film

Aquestive Reports Positive Results from Sublingual Epinephrine Clinical Trial

Phase 2 study continues to show AQST-109 is safe and well tolerated.
Aquestive AQST-109 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.
Aquestive AQST-109 Epinephrine Film

Sublingual Emergency Epinephrine Takes Another Step Forward in Phase 1 Study

Aquestive's postage-stamp-sized film is designed to dissolve under the tongue to provide epinephrine.
Food Allergy Collaborative

Tell the FDA: Join the Patient-Focused Drug Development Meeting for Food...

Your opportunity to participate in a discussion with the FDA about your experiences with food allergies.
Aquestive AQST-109 Epinephrine Film

Aquestive’s Sublingual Epinephrine Film Receives FDA Fast Track Designation for Treatment...

First planned PK clinical trial expected to begin during the third quarter of 2020.
Nose

Bryn Pharma Completes Dosing in Pivotal Clinical Trial Designed to Support...

Nasal Spray Product is Disruptive Innovation for People at Risk of Anaphylaxis.
Viaskin Peanut

DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut...

If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
Viaskin Patch

DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut...

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
Nose

FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray

Company provides a novel means of administering emergency epinephrine.
Nasal Spray

FDA Grants Fast Track Designation for Epinephrine Nasal Spray as Investigational...

"A significant milestone for INSYS and our clinical development of this novel drug-device combination.”