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Omalizumab News

American Academy of Allergy, Asthma & Immunology, Feb. 28-March 3

The annual meeting of the American Academy of Allergy, Asthma & Immunology was held from Feb. 28 to March 3 in San Diego, drawing clinicians, academicians, allied health professionals, and others i...

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ – Celltrion today announced the U.S. Food and Drug Administration (FDA) approved Omlyclo® (omalizumab-igec) as the first and only biosimilar designated a...

AAAAI: Omalizumab Superior to Oral Immunotherapy in Multifood Allergy

MONDAY, March 3, 2025 – Omalizumab is superior to oral immunotherapy (OIT) for multifood allergy, and most patients include dietary consumption (DC) of allergy-triggering foods after gaining...

FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

South San Francisco, CA – February 16, 2024 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved...

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

South San Francisco, CA – April 12, 2021 – 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...

Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps

South San Francisco, CA – December 1, 2020 – 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...

FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children

South San Francisco, CA – July 7, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Xolair...

FDA Medwatch Alert: Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

ISSUE: An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug...

FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria

South San Francisco, Calif. – March 21, 2014 – Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) for the...

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Further information

Related condition support groups

Urticaria, Hives, Nasal Polyps, Asthma - Maintenance, Chronic Rhinosinusitis with Nasal Polyps, Asthma

Related drug support groups

Xolair

Omalizumab patient information at Drugs.com