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 ...

The FDA will issue a decision on odronextamab’s accelerated approval in relapsed/refractory follicular lymphoma by 30 July ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License ...

(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 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 ...

follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. Regeneron stated that the sole issue with approvability is related to ...

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the ...

The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for ...

The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...

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.

The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...