So, Axatilimab by Incyte was approved on their first BLA for the product. There was no inspection needed as it is produced in a location which has previously been inspected by the FDA for similar monoclonal antibody treatments.
All brand new data for the FDA, Class 2 -6 month review timeline and received approval 2 weeks ahead of the PDUFA date.
The Incyte company page doesn't show incremental update about the BLA progress at all. Just the notice of submission and then notice of approval.
So, Axatilimab by Incyte was approved on their first BLA for the...
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