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FDA turns down Pfizer's Xeljanz in psoriasis

from PMLive

The U.S. regulator sent Pfizer a Complete Response Letter (CRL) indicating that it would be unable to approve Xeljanz (tofacitinib) for psoriasis without additional information, thought to relate to the safety of the drug. In a statement, Pfizer said it would work with the FDA to resolve the deficiencies in the dossier, and said this could include "providing additional safety analyses of Xeljanz for the proposed indication." more


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