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- Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancerMerck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
- FDA offers guidance for smoother BLA submissions and outlines biosimilar review changesSubmitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…