In an unscripted moment of synchronicity, the complete response letter for linvoseltamab announced by Regeneron Pharmaceuticals, Inc. on 20 August exemplified the findings of a US Food and Drug Administration analysis of biologics approvals presented to a Duke-Margolis Institute for Health Policy meeting the same day.
Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers
The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
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