2022-11-23 08:31:52 BMRN BioMarin
11/23/22 11/2308:31 11/23/2208:31 | BioMarin: FDA does not plan to hold meeting to discuss BLA for ROCTAVIANBioMarin Pharmaceutical announced advancements in the U.S. FDA review of the Biologics License Application of ROCTAVIAN for adults with severe hemophilia A. The company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the company that it did intend to hold an advisory committee meeting but did not specify a date. The company also remains on track to host the scheduled FDA Pre-Licensure Inspection of BioMarin's gene therapy manufacturing facility located in Novato, CA. |
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