Allergy

 
Neffy Update: FDA to Review 1 mg Version in First Quarter 2025, for Young Children with Type 1 Allergic Reactions
January 14, 2025

If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.

Orexo Announces Positive Topline Data for Nasal Epinephrine Powder OX640 in People with Allergic Rhinitis
January 10, 2025

Treatments with the investigational rescue medication achieved clinically effective epinephrine levels faster than intramuscular injection.

American College of Gastroenterology Releases Updated Guidelines for Eosinophilic Esophagitis
January 07, 2025

The updated guidelines include 19 recommendations related to the diagnosis and management of eosinophilic esophagitis.

NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says
December 03, 2024

Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.

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 Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.

Orexo Launches New OX640 Clinical Trial in People with Allergic Rhinitis
October 25, 2024

The company is advancing development of the intranasal epinephrine medication following positive phase 1 data.

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.