Tag: FDA Fast Track Designation

Aquestive AQST-108 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.”