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FDA Moves Toward Non-Animal Testing for Biologics Preclinical Studies

The FDA recently announced plans to phase in non-animal testing methods—starting with monoclonal antibodies—in preclinical research. This policy shift marks a major move toward modernizing drug development, potentially reducing animal use while enhancing the accuracy of safety testing for immune-related therapies

July 23, 2025

FDA Extends Review of GSK’s Blenrep for Multiple Myeloma

The FDA has postponed its decision on GSK's blood cancer drug, Blenrep (belantamab mafodotin), when used in combination therapy for relapsed or refractory multiple myeloma. This marks a delay until October 23, 2025, as regulators assess additional data following concerns raised by an advisory committee about side effects, notably eye toxicity, and uncertain efficacy. Blenrep was previously withdrawn in 2022 and now faces renewed scrutiny before a potential U.S. return

July 23, 2025

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