Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But after the recent approval of neffy, the San Diego drugmaker is poised for an October launch and a “blue sky opportunity,” according to analysts at Leerink Partners.
Aptar Group, a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced that its Unidose Liquid System (Unidose) is the delivery system approved with neffy® (epinephrine nasal spray), the first and only needle-free treatment approved by the U.S. FDA for the emergency treatment of patients with allergic reactions (Type I), including anaphylaxis. This marks the first regulatory approval worldwide for nasally-delivered epinephrine.
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
neffy® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early October 2024 EURneffy® (adrenaline nasal...
Late-stage pipeline program, Anaphylm™ (epinephrine) Sublingual Film, remains on track for a near-term New Drug Application (NDA) submission to the FDAExpanded sales coverage for Libervant™ (diazepam)...
TEL AVIV, Israel, Aug. 6, 2024 /PRNewswire/ -- Nasus Pharma Ltd, a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the results of a 5 years stability study of its FMXIN002 drug candidate – nasal powder epinephrine for the treatment of severe allergy and anaphylactic shock.
Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs)Final supportive study, the Oral Allergy Syndrome...
De Motu Cordis (DMC) unveiled plans for the next stage of development with its contract development and manufacturing organization (CDMO) partner, Catalent, at Catalent's Boston, Morrisville and San Diego sites. These expansion plans encompass services from drug product manufacturing and device assembly through to commercial launch of DMC's product, DMC-IH1. DMC-IH1 is an inhaled epinephrine drug-device combination product being developed for the treatment of anaphylaxis using a dry powder inhaler (DPI).
BRISBANE, Australia, July 17, 2024 /PRNewswire/ -- De Motu Cordis (DMC) today announced plans for the next stage of development with its Contract Development and Manufacturing Organization (CDMO) partner, Catalent, at Catalent's Boston, Morrisville and San Diego sites. These expansion plans encompass services from drug product manufacturing and device assembly through to commercial launch of DMC's product, DMC-IH1. DMC-IH1 is an inhaled epinephrine drug-device combination product being developed for the treatment of anaphylaxis using a dry powder inhaler (DPI).
RALEIGH, NC / ACCESSWIRE / July 9, 2024 / Belhaven Biopharma, a leader in emergency use dry powder nasal products, announces the promising results of their latest nonclinical study comparing the pharmacokinetics of dry powder nasal epinephrine to the traditional autoinjector in a canine model. The findings, presented at Respiratory Drug Delivery (RDD) 2024, signify a potential breakthrough treatment for patients with severe allergies at risk of anaphylactic reactions.