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 ...

(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 ...

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

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the 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 ...

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

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 ...

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

Regeneron Pharmaceuticals is taking another shot at US Food and Drug Administration (FDA) accelerated approval for odronextamab in relapsed/refractory follicular lymphoma (r/r FL), with the agency ...