Tag: ARS Pharmaceuticals
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.
FDA Delays Approval of neffy™ Intranasal Epinephrine Until September
The expected approval date has been delayed from mid-year.
Viatris, Seller of EpiPen®, Petitions FDA to Delay Approval of neffy™...
A ploy to delay introduction of neffy.
FDA Panel Supports Approval of neffy® Epinephrine Nasal Spray
The first needle-free emergency epinephrine alternative is on the verge of FDA approval.
Hoping Needle-Free Intranasal Epinephrine will be Approved? Tell the FDA!
Your testimony is important and there are two ways you can participate.
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.
They’re Coming: Needle-Free Emergency Epinephrine Options Currently in Trials
For some, the needle is a barrier to administration but alternatives are on the horizon.
