March 28th 2025
Your daily dose of the clinical news you may have missed.
March 24th 2025
March 17th 2025
March 14th 2025
March 13th 2025
FDA Approves Omlyclo as First Interchangeable Omalizumab Biosimilar
Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
FDA Approves Neffy 1 mg Epinephrine Nasal Spray, Only Needle-Free Treatment for Patients Weighing Less Than 30 kg
The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.
Omalizumab Efficacy and Safety Shown Superior to OIT in First Head-to-Head Multi-Food Allergy Trial
Safety findings from the phase 3 OUtMATCH trial were notable, including no adverse events for omlizumab vs 30.5% for OIT and epinephrine use for 0% vs 37.3%, respectively.
Epinephrine Nasal Spray Shows Rapid Symptom Relief in Pediatric Anaphylaxis Study
Participants (aged 6 to 17 years) receiving neffy vs standard treatments had fewer skin, gastrointestinal, and respiratory symptoms at 15, 5, and 5 minutes, respectively.
Dupilumab Reduces Specific IgE to Foods at 12 and 24 Months in Small Study
AAAAI 2025: Dupilumab was associated with a 56.9% reduction in IgE levels at 12 months and of 73.5% at 24 months, according to results presented at AAAAI 2025.
Home-Based Therapy Achieves 100% Success Rate in Children with High-Threshold Peanut Allergy
AAAAI 2025: Phase 2 study results showed POIT with home-measured peanut products was not only highly effective but also posed few risks.
AAAAI 2025: Omalizumab Shows Favorable Outcomes Versus Oral Immunotherapy in Multi‐Food Allergy Treatment
In a randomized clinical trial, omalizumab achieved a 36% treatment success rate for multi-food allergy compared with 19% for oral immunotherapy.
Neffy Update: FDA to Review 1 mg Version in First Quarter 2025, for Young Children with Type 1 Allergic Reactions
If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.