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.
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.
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
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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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FDA Accepts BLA Reubmission For Regeneron's Odronextamab In Follicular Lymphoma
follicular lymphoma (FL). The regulator accepted BLA resubmission after Regeneron achieved the FDA-mandated enrollment target for the Phase 3 confirmatory trial. In the previous submission ...
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FDA reviews Regeneron's lymphoma drug application
For deeper insights into Regeneron's financial health and growth potential, InvestingPro subscribers can access comprehensive analysis and 8 additional ProTips. Follicular lymphoma, a common ...