EMA CHMP recommends approval for biosimilar Denosumab Ascend and Nylaspeg, recommends against Tacquell

China has outpaced the U.S. in novel cancer drug approvals since 2023, Friends analysis shows

China approved more novel oncology drugs than the United States from 2020 to 2025, according to a new analysis from Friends of Cancer Research  published in Health Affairs Scholar.

EMA approves phase III clinical study of Alpha1H bladder cancer therapy

Alpha1H has received regulatory approval from the European Medicines Agency for its phase III clinical study of the therapy in bladder cancer. The approval represents a milestone for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe.

July 24, 2026

Vol.52 No.29

Drugs & Targets

FDA approves Trodelvy for first-line treatment of mTNBC

FDA approved Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate, for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.

July 02, 2026

Vol.52 No.26

Drugs & Targets

FDA approves Tregzi for chronic graft-versus-host disease

FDA approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.

July 02, 2026

Vol.52 No.26

Drugs & Targets

FDA accepts sBLA for atezolizumab for patients with stage 3 dMMR colon cancer

FDA has accepted for review Genentech’s supplemental Biologic License Application for their immunotherapy drug atezolizumab (Tecentriq) for the treatment of patients with stage 3 colon cancer with deficient deoxyribonucleic acid mismatch repair.

June 18, 2026

Vol.52 No.24

Drugs & Targets

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

May 22, 2026

Vol.52 No.20

EMA CHMP recommends approval for biosimilar Denosumab Ascend and Nylaspeg, recommends against Tacquell

YOU MAY BE INTERESTED IN

China has outpaced the U.S. in novel cancer drug approvals since 2023, Friends analysis shows

EMA approves phase III clinical study of Alpha1H bladder cancer therapy

FDA approves Trodelvy for first-line treatment of mTNBC

FDA approves Tregzi for chronic graft-versus-host disease

FDA accepts sBLA for atezolizumab for patients with stage 3 dMMR colon cancer

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

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