FDA Accepts Odronextamab Lymphoma Drug Resubmission
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.
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving ...
A year after the FDA rejected its marketing application for CD20xCD3 bispecific antibody odronextamab to treat two common ...
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Regeneron 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 ...
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 ...
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the ...
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 ...
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