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'A Real Regulatory Dilemma Here': What We Heard This Week - MSN
-- Donald Kohn, MD, of the University of California Los Angeles, at an FDA advisory committee meeting to discuss whether the bleeding reversal agent andexanet alfa (Andexxa) should get full approval.
The Committee discusses and makes recommendations for AstraZeneca (AZN) supplemental Biologics License Application (sBLA) 125586/546 for Andexxa (coagulation factor Xa (recombinant), inactivated ...
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