UCB expects further delay to FDA decision on Bimzelx

20 September 2023
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Belgian drugmaker UCB (Euronext: UCB) is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.

Following a previous rejection by the agency, the FDA accepted the BLA for review in December last year and hosted a pre-license inspection at its Belgian manufacturing facility in April.

Review goes on

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