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 Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.
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.
The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.
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The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.
neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.
PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.