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

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

follicular lymphoma (FL) after 2 or more lines of systemic therapy. Odronextamab is an investigational bispecific antibody that binds to CD20 expressed on the surface of B cells, and to CD3 ...

Antengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug ...

The National Institute for Health and Care Excellence (NICE) has approved a chimeric antigen receptor (CAR) T-cell therapy for adults with large B-cell lymphoma. The treatment significantly delays ...

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance ...

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

Genmab (GMAB) announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY or epcoritamab, for the treatment of ...

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 ...