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Home » EU clears Regeneron’s Ordspono, Merck’s Winrevair, ARS’ Eurneffy
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EU clears Regeneron’s Ordspono, Merck’s Winrevair, ARS’ Eurneffy

Aug. 26, 2024
By Nuala Moran
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
BioWorld Regulatory Cancer Cardiovascular Immune Bispecific antibody Protein Small molecule Europe

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