Tag: FDA Fast Track Designation
Siolta Begins Phase 2 Study in Newborns of Bacteria Consortia ...
STMC-103H has a combination of bacteria that are depleted in the gut microbiota of infants who go on to develop allergic sensitization and allergic diseases in childhood.
Aquestive Reports Positive Results from Sublingual Epinephrine Clinical Trial
Phase 2 study continues to show AQST-109 is safe and well tolerated.
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.
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.
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’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.
Bryn Pharma Completes Dosing in Pivotal Clinical Trial Designed to Support...
Nasal Spray Product is Disruptive Innovation for People at Risk of Anaphylaxis.
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.
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.
FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray
Company provides a novel means of administering emergency epinephrine.
