12:00 AM
Nov 23, 2009
 |  BC Week In Review  |  Clinical News  |  Regulatory

Raxibacumab regulatory update

Human Genome Sciences said it received a complete response letter from FDA for a BLA for raxibacumab to treat inhalation anthrax. Human Genome said the agency requested additional information to complete the review. The company did not disclose what information the agency is seeking but did say that "in certain respects, the Complete Response Letter appears to be inconsistent with the FDA's...

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