Tag: ARS Pharmaceuticals

Dave Bloom RE neffy denial by the FDA

Why the FDA Changed Course at the Last Minute to Deny...

Did the FDA kowtow to corporate greed?
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 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.
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 Advisory Committee

Hoping Needle-Free Intranasal Epinephrine will be Approved? Tell the FDA!

Your testimony is important and there are two ways you can participate.
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.
Needless Epinephrine Alternatives

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.