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sdm Insights
July 23, 2025 GSK disclosed that the FDA has postponed PDUFA date of the Blenrep® (belantamab mafodotin) combination therapy BLA. The agency established a new action date of October 23, 2025 for completion of BLA review.
this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.
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