On October 5, 2026, Celltrion USA announced that OMLYCLO® (omalizumab-igec) is commercially available in the United States. OMLYCLO® is the first ...
Kaléo, a Glen Allen, Virginia-based drug-delivery device and auto-injector company, announced on October 7, 2026 that it has ...
Celltrion USA announced on October 5, 2026, that Omlyclo (omalizumab-igec), the first FDA-approved interchangeable biosimilar ...
Celltrion USA, Inc. today announced the availability of OMLYCLO® (omalizumab-igec), the first and only U.S. Food and Drug Administration (FDA) approved interchangeable biosimilar to XOLAIR® ...
A midstage study of Cue Biopharma’s hives drug candidate has hit its primary endpoint, emboldening the biotech to move the would-be challenger to Xolair into a phase 2b/3 trial. In April, Cue paid ...
A head-to-head trial found that continued omalizumab achieved higher overall treatment success than omalizumab-facilitated multiallergen oral immunotherapy, largely by helping patients avoid the ...
About a third of children with multiple food allergies gained the ability to safely eat full servings of foods that trigger their allergies in a new Stanford Medicine-led clinical trial. The results ...
On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair ® (omalizumab), TEV-45779. The submissions ...
Clinical data from a phase 3 trial show Ponlimsi has comparable safety and efficacy to Prolia in women with postmenopausal osteoporosis. The Food and Drug Administration (FDA) has approved Ponlimsi ™ ...