FDA Accepts Odronextamab Lymphoma Drug Resubmission

Regeneron gets FDA Review acceptance for odronextamab's resubmitted BLA
Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License Application for odronextamab, a treatment for patients with relapsed or refractory follicular lymphoma who have undergone at least two prior therapies.
Regeneron: FDA Accepts Odronextamab Lymphoma Drug Resubmission
Regeneron last year won European Commission approval of odronextamab as Ordspono for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy. Write to Colin Kellaher at [email protected]
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma
The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after phase 3 trial enrollment milestone.
Odronextamab BLA resubmission accepted for FDA review
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Regeneron announces FDA accepted for review BLA for odronextamab
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the
FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
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The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving ...
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A year after the FDA rejected its marketing application for CD20xCD3 bispecific antibody odronextamab to treat two common ...
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The FDA will issue a decision on odronextamab’s accelerated approval in relapsed/refractory follicular lymphoma by 30 July ...
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Follicular Lymphoma: Emerging Therapeutic Strategies
Follicular lymphoma is a diverse disease, both biologically and clinically. Patients may present with indolent, asymptomatic disease or more aggressive, symptomatic disease with high tumor burden.
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REGN Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals ... Evkeeza for treatment of HoFH; Ordspono for Follicular lymphoma and Diffuse large B-cell lymphoma; and Veopoz for CD55-deficient protein-losing enteropathy.