Tag: Richard Lowenthal

ARS-FDA

ARS Responds to FDA’s Request for Additional Study Before Approving neffy...

FDA Issues Complete Response Letter for neffy® New Drug Application with Request for Additional Study.
neffy®

FDA Delays Approval of neffy™ Intranasal Epinephrine Until September

The expected approval date has been delayed from mid-year.
neffy®

FDA Panel Supports Approval of neffy® Epinephrine Nasal Spray

The first needle-free emergency epinephrine alternative is on the verge of FDA approval.
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.
neffy®

FDA Accepts New Drug Application for Nasal Epinephrine Spray Treatment for...

If approved, acceptance targeted for mid-2023.
Neffy Intranasal Epinephrine Device

CEO Expects Approval and Launch of Intranasal Emergency Epinephrine Spray by...

The market for epinephrine delivery may expand to include non-needle alternatives next year.
Intranasal Spray

Emergency Epinephrine Nasal Spray Takes Final Step Toward Approval in EU

A needle-free option for administration of epinephrine is on the horizon.
Neffy Intranasal Epinephrine Device

ARS Pharmaceuticals Announces New Patent on ARS-1 (Epinephrine Nasal Spray)

Intranasal delivery of emergency epinephrine takes another step closer to becoming a reality.
Nose

ARS to Present Data from Intranasal Epinephrine (ARS-1) Studies at AAAAI...

Neffy™ (formally ARS-1) was fast-tracked by the FDA in 2019 as an intranasal alternative to epinephrine auto-injectors.
Nose

FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray

Company provides a novel means of administering emergency epinephrine.