Allergy

 
sNDA Goes to FDA for neffy 1 mg for Young Children with Type 1 Allergic Reactions
September 11, 2024

The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.

FDA Approves Neffy as First Nasal Spray for Allergic Reactions: Daily Dose
August 20, 2024

Your daily dose of the clinical news you may have missed.

Neffy, First Needle-Free Epinephrine, Fills a Deep Need for Patients, says Allergy Expert
August 15, 2024

The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.

FDA Approves First Intranasal Epinephrine for Emergency Treatment of Allergic Reactions
August 09, 2024

neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.

Topline PK Data Released on Self-Administered Epinephrine Sublingual Film for Severe Allergy
July 26, 2024

PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.

ARS Pharma Submits Response to FDA Complete Response Letter for neffy (epinephrine nasal spray)
April 03, 2024

Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.

Optinose Xhance approved by FDA as first medical therapy for CRS
March 15, 2024

Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.

Neffy May be Safe, Effective for Treatment of Urticaria Flares: Daily Dose
March 07, 2024

Your daily dose of the clinical news you may have missed.

Phase 3 Findings on Neffy for Pediatric Patients with Severe Allergies: A Conversation with Motohiro Ebisawa, MD, PhD
March 04, 2024

Dr Ebisawa details the findings he recently presented at the 2024 AAAAI annual meeting, including adverse events and next steps for the study.

Needle-free Epinephrine Delivery: Perceptions of Physicians, Patients, and Caregivers
February 27, 2024

AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.