Regulatory

Regulatory  ·  Weekly Digest 12 July to 18 July 2025
ENHERTU plus Pertuzumab granted breakthrough therapy designation in the U.S. as first-line therapy for patients with HER2 positive metastatic breast cancer

Weekly Digest – July 2025 Weekly Digest – July 2025 17 July 2025: ENHERTU plus Pertuzumab granted breakthrough therapy designation in the U.S. as first-line therapy for patients with HER2 positive metastatic breast cancer ENHERTU (Trastuzumab deruxtecan) plus Pertuzumab has […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 12 July to 18 July 2025
FDA advisors spurn GSK’s Blenrep comeback dreams on safety, trial concerns

Weekly Digest – July 2025 Weekly Digest – July 2025 17 July 2025: FDA advisors spurn GSK’s Blenrep comeback dreams on safety, trial concerns The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against GSK’s efforts to reintroduce its multiple myeloma […]

by Sandhya Ramalingam

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