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Bristol's Belatacept Gets Wary Green Light From FDA Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

The company proposed a REMS in advance for the kidney transplant drug, and post-market safety monitoring is indeed essential, committee members said.

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Bristol's Belatacept Could See Approval In Second Quarter After GMP Delay

The kidney transplant drug Nulojix (belatacept) is finished at the plant in Puerto Rico that won't be inspection-ready until the end of the year following a August warning letter.

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