Biosimilar drugs

FDA again delays Portola’s BLA for bleeding antidote

The bleeding Antidotes have been delay again by FDA. Portola Pharmaceuticals is faced with getting its AndexXa universal bleeding reversal agent considered for approval by the FDA.

Pfizer and Bristol-Myers Squibb, as well as Bayer and Johnson & Johnson, were hoping to hear that a bleeding antidote for their blood thinners Eliquis and Xarelto would be approved early next year. Instead they will have to wait at least until spring after the FDA again delayed consideration of AndexXa, a universal bleeding reversal agent being developed by Portola Pharmaceuticals.

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