The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is a three-stage, multicenter, randomized, ...

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure Interim analysis results from first-of-its-kind phase III OUtMATCH study ...

Please provide your email address to receive an email when new articles are posted on . Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was ...

Findings showed equivalent efficacy in change from baseline in weekly itch severity score between omalizumab-igec 300mg and Xolair 300mg. The Food and Drug Administration (FDA) has approved Omlyclo ® ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the ...

Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and ...

SAN DIEGO -- Omalizumab (Xolair) injections outperformed oral immunotherapy (OIT) in increasing tolerance among children with multi-food allergy, largely because many patients couldn't tolerate OIT, ...

On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar to ...

Amneal is expanding its portfolio with omalizumab, a proposed biosimilar of Novartis AG’s Xolair. Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E. It is an injectable ...

EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted, under ...