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BioWorld - Thursday, April 30, 2026

Priority review

Home » Topics » Regulatory » Priority review
  • Lung cancer
    April 21, 2026
    By Marian (YoonJee) Chu

    FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

    The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
  • Lung cancer
    April 16, 2026
    By Marian (YoonJee) Chu

    FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

    The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
  • Oral medication
    March 30, 2026
    By Nuala Moran

    AAD 2026: Targeted oral therapies challenge injected biologics

    Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
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Authors

  • Jennifer Boggs
  • Karen Carey
  • Lee Landenberger
  • Nuala Moran
  • Marian (YoonJee) Chu
More Authors
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