FDA Delays Decision For Regeneron's Inaugural Blood Cancer Therapy, Highlights Trial Concerns - Regeneron Pharmaceuticals (NASDAQ:REGN)
The FDA issues complete response letters to Regeneron Pharmaceuticals Inc's BLA for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, requesting more trial data without concerns about efficacy, safety, or design. Regulatory review continues with the EMA.