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Monday, the FDA issued complete response letters (CRL) to Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The FDA said it needs more data from enrollments in dose-finding and confirmatory portions of trials while confirming no issues with clinical efficacy or safety, trial design, labeling, or manufacturing. Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronex…

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