The Trentonian

Novartis receives FDA approval of Xolair(R) (omalizumab) self-injection with prefilled syringe across all indications for appropriate patients

EAST HANOVER, N.J., April 12, 2021 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair (R) ...
Nasdaq

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

– Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatment – “Today's approval reflects our ...
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 ...
Healio

FDA approves self-injectable formulation of Xolair

Please provide your email address to receive an email when new articles are posted on . The FDA has approved a self-injectable formulation of Xolair for appropriate patients with moderate to severe ...
FOX 5 Atlanta

FDA authorizes new treatment for accidental food allergy exposures

ATLANTA - If you have to be vigilant about what you eat, and keep an EpiPen close, Dr. Tom Chacko of Chacko Allergy, Asthma and Sinus Center, says the newly FDA-authorized allergy medication, Xolair, ...
Business Wire

Xolair (Omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults with Chronic Rhinosinusitis with Nasal Polyps in Two Phase III Studies

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline data from two Phase III multicenter studies ...
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 ...
Healthline

Xolair: How It’s Used for Treating Hives

Xolair (omalizumab) is a prescription drug used to treat chronic (ongoing) hives without a known cause. Xolair is a biologic drug and does not come in a biosimilar version. It’s used when symptoms ...
CNN

New data shows asthma medicine may help reduce severe reactions in people with multiple food allergies

A new study finds that the asthma medication Xolair may substantially reduce severe allergic reactions in people who have multiple food allergies and are accidentally exposed to those foods. Data ...
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 ...
Nasdaq

FDA Approves Roche's Xolair Prefilled Syringe For Self-Injection Across All Indications

(RTTNews) - Roche (RHHBY) said Tuesday that it has received an approval from the U.S. Food and Drug Administration for its supplemental Biologics License Application of Xolair or omalizumab prefilled ...