Celltrion USA completes submission of BLA to U.S. FDA for CT-P39
Feb 25 (Reuters) - Xolair, a 20-year-old asthma drug sold by Roche (ROG.S), opens new tab and Novartis (NOVN.S), opens new tab, significantly reduced allergic reactions in people with multiple severe food allergies in a late-stage trial, researchers reported on Sunday at a medical meeting.
Xolair becomes first medicine approved in US for food allergy
Genentech`s Biologic Xolair (omalizumab) Receives Approval in the U.S.
Novartis Ends PIII Peanut Allergy Trial in Another Flop for Xolair Successor
Genentech’s Xolair scored a priority review from the FDA on Wednesday for the reduction of allergic reactions in adult and pediatric patients 1 year and older, the company said, with the agency expected to make a decision in the first quarter of 2024.
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposureInterim analysis results from first-of-its-kind phase III OUtMATCH study...
Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR® (omalizumab)
PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv” or the “Company”) today announced that ADL018, a biosimilar candidate to Xolair® (omalizumab), completed a successful global Phase 1 clinical study in healthy volunteers.
Genentech's Biologic Xolair (Omalizumab) Receives Approval in the U.S.