Tag: intranasal delivery
Anaphylaxis Guidelines Regarding What to Do After Administering Epinephrine Expected to...
Paradigm shift based on data and cost-effectiveness analyses.
Positive Results Reported for Bryn Pharma’s Epinephrine Nasal Spray in Adults...
If approved, NDS1C may offer patients at risk of anaphylaxis a practical alternative to needle-based administration routes.
Clinical Data Supporting neffy® Epinephrine Nasal Spray Presented at Scientific Meeting
Data builds the case for prompt FDA approval.
Food Allergy Advocacy Sends Petition with First 20,000 Signatures to FDA...
Petition garnered 20K signatures in first week highlighting the need for approval of this lifesaving alternative.
Take Action: The FDA MUST Approve Nasal Epinephrine
We need your participation to convince the FDA to act.
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 Denies Approval of Needle-Free Alternative to Epinephrine Auto-injectors
The rejection was unexpected based on feedback from the FDA's expert panel in June.
Needle-Free Powder Epinephrine Nasal Spray Shows Positive Results in Clinical Study
"Powder-based products are also known to have better stability, as compared to the solution-based products."
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.
