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Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved

Executive Summary

The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.

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FDA’s decision to seek two more years of data for BioMarin’s gene therapy for hemophilia A ‘makes perfect sense,’ Harvard Pilgrim Health Care’s Michael Sherman says.

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The anti-CD20 monoclonal antibody was approved by the US FDA for relapsing multiple sclerosis, bringing a new treatment to the crowded therapeutic area – with the benefit of self-administration. 

Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian

BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.

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