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- J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemiaJ&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
- FDA releases draft guidance on potency testing for immunotherapy productsThe FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…