Matthew Matasar, MD, discusses odronextamab and the ongoing phase 1 ELM-1 trial in patients with CD20-positive B-cell malignancies.
FDA decision expected by July 30, 2025TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) ...
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...
A regulatory decision on odronextamab for R/R FL is expected by July 30, 2025. The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA ...
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...
Odronextamab is approved as Ordsponoâ„¢ in the European Union for the treatment of R/R FL or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy although its safety ...
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for ...
A year after the FDA rejected its marketing application for CD20xCD3 bispecific antibody odronextamab to treat two common ...
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GlobalData on MSNRegeneron makes second bid for blood cancer therapy approvalThe FDA will issue a decision on odronextamab’s accelerated approval in relapsed/refractory follicular lymphoma by 30 July ...
Regeneron Narrows Approval Aspirations for Lymphoma Bispecific, Citing ‘Competitor Developments’
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving ...
About the Odronextamab Clinical Development ProgramOdronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...
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