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FDA approves Rezdiffra & Xolair

03/22/2024 9:33 AM | Anonymous member (Administrator)

The FDA has granted accelerated approval to Rezdiffra (resmetirom), making it the first FDA-approved medication available for non-alcoholic steatohepatitis (NASH). It is approved for adults with noncirrhotic NASH with moderate to advanced liver fibrosis to be used in conjunction with diet and exercise. Approval was based on data from the Phase 3 MAESTRO-NASH trial. Read more here.


Xolair (omalizumab) has been granted FDA approval for IgE-mediated food allergy in adult and pediatric patients 1 year of age and older for the reduction of Type 1 allergic reactions that may occur with accidental exposure to one or more foods. Patients who receive Xolair must continue to avoid the food allergen, and Xolair is not intended for emergency treatment of allergic food reactions. Read more here.

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