Monthly Prescribing Reference

Xolair for the Treatment of IgE-Mediated Food Allergies

In February 2024, the US Food and Drug Administration (FDA) approved Xolair (omalizumab; Genentech, Inc), an anti-immunoglobulin E (IgE) antibody, for the treatment of IgE-mediated food allergies in ...
Business Wire

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

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 ...
Business Wire

FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results

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 ...
WebMD

Xolair: The First FDA-Approved Injection for Chronic Hives

If you or someone you know has a condition called chronic spontaneous urticaria (CSU), you may have heard about Xolair. In 2014, Xolair became the first medicine to be approved for treating this ...
Pharmabiz

US FDA approves Roche’s Xolair prefilled syringe for self-injection across all indications

Roche announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) prefilled syringe for self-injection ...