Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian
Company’s Hemophilia A Gene Therapy Gets A CRL
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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The company plans to file with 52-week data for AMT-061 and is confident it won't face the same stringent requirements from the FDA that led to a complete response letter for BioMarin's Roctavian.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
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.