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- Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficientMerck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
- FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviewsThe U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…