ARS PHARMACEUTICALS

ALK and ARS Pharmaceuticals have entered a four-year co-promotion agreement for Neffy, the only FDA-approved needle-free epinephrine nasal spray for treating anaphylaxis, targeting 9,000 US pediatricians.

The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray).

• Dupilumab (Dupixent) gains FDA approval as the first treatment specifically for children aged 1-11 with eosinophilic esophagitis, addressing a critical unmet need for this age group. • Epinephrine nasal spray (Neffy) is approved as the first nasal spray for anaphylaxis treatment in adults and children over 66 lbs, offering a needle-free alternative for emergency use. • Roflumilast cream 0.15% (Zoryve) receives FDA approval for mild to moderate atopic dermatitis in patients aged 6 and older, providing a new nonsteroidal option.

ARS Pharmaceuticals' licensing partners have filed for approval of Neffy® (epinephrine nasal spray) in China, Japan, and Australia.

ARS Pharmaceuticals активно продвигает Neffy (назальный спрей эпинефрина) в США в качестве первого и единственного безъигольного лечения анафилаксии.

ARS Pharmaceuticals' Neffy, an epinephrine nasal spray, has received FDA approval, offering a needle-free alternative to EpiPens for allergic reactions.

Pre-ordering has commenced for Neffy, an epinephrine nasal spray, offering a needle-free option for treating anaphylaxis in adults and children.

ARS Pharmaceuticals seeks FDA approval for Neffy 1 mg to treat type 1 allergic reactions, including anaphylaxis, in children weighing 33-66 lbs..