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Regeneron tries again with lymphoma bispecific in US
A year after the FDA rejected its marketing application for CD20xCD3 bispecific antibody odronextamab to treat two common ...
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Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European ...
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 ...
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 ...
BioSpace4d
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 ...
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 ...
GlobalData on MSN4d
Regeneron makes second bid for blood cancer therapy approval
The FDA will issue a decision on odronextamab’s accelerated approval in relapsed/refractory follicular lymphoma by 30 July ...
Regeneron Pharmaceuticals, Inc.: Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...
Nasdaq5d
Regeneron Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Odronextamab in Relapsed/Refractory Follicular Lymphoma
Regeneron Pharmaceuticals announced that the FDA has accepted for review its resubmission of the Biologics License Application (BLA) for odronextamab, a treatment for relapsed/refractory ...