Tag: Richard Lowenthal
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.
FDA Delays Approval of neffy™ Intranasal Epinephrine Until September
The expected approval date has been delayed from mid-year.
FDA Panel Supports Approval of neffy® Epinephrine Nasal Spray
The first needle-free emergency epinephrine alternative is on the verge of FDA approval.
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.
FDA Accepts New Drug Application for Nasal Epinephrine Spray Treatment for...
If approved, acceptance targeted for mid-2023.
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.
Emergency Epinephrine Nasal Spray Takes Final Step Toward Approval in EU
A needle-free option for administration of epinephrine is on the horizon.
ARS Pharmaceuticals Announces New Patent on ARS-1 (Epinephrine Nasal Spray)
Intranasal delivery of emergency epinephrine takes another step closer to becoming a reality.
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.
FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray
Company provides a novel means of administering emergency epinephrine.
