If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.
Treatments with the investigational rescue medication achieved clinically effective epinephrine levels faster than intramuscular injection.
The updated guidelines include 19 recommendations related to the diagnosis and management of eosinophilic esophagitis.
Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.
The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.
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.
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 Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.
The company is advancing development of the intranasal epinephrine medication following positive phase 1 data.
A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.