Allergy

 
FDA Accepts Dupilumab sBLA for Review for Treatment of Chronic Spontaneous Urticaria
November 15, 2024

The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.

FDA May End Use of Oral Phenylephrine as Nasal Decongestant Ingredient in OTC Products
November 08, 2024

A decision on ending use of oral phenylephrine as a nasal decongestant in OTC products will be made following public comment on FDA's proposed order.

Knowledge Gaps in How to Manage Anaphylaxis, Epinephrine Use, Persist for Patients, Even EMS
October 28, 2024

ACAAI 2024. Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.

New Data on Needle Free Epinephrine Spray Presented at ACAAI 2024
October 25, 2024

A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

7 Drugs Approved for Primary Care: Q3 2024
September 26, 2024

Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.

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.