The FDA has accepted the resubmission of the BLA of Ordspono for review in relapsed/refractory follicular lymphoma following previous systemic therapy.

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

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

Matthew Matasar, MD, discusses odronextamab and the ongoing phase 1 ELM-1 trial in patients with CD20-positive B-cell malignancies.

A year after the FDA rejected its marketing application for CD20xCD3 bispecific antibody odronextamab to treat two common ...

FDA decision expected by July 30, 2025TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) ...

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 ...

Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European ...

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

Odronextamab is already approved in the EU under the name Ordspono™ for similar indications. The ongoing clinical development program for odronextamab includes evaluations as both a monotherapy ...