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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Regulatory

Regulatory  ·  Weekly Digest - 13 December to 19 December 2025
DATROWAY Type II Variation Application validated in the EU as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy

Weekly Digest – December 2025 Weekly Digest – December 2025 18 December 2025: DATROWAY Type II Variation Application validated in the EU as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy The […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 13 December to 19 December 2025
JSKN003 was granted Breakthrough Therapy Designation by the FDA for the treatment of PROC

Weekly Digest – December 2025 Weekly Digest – December 2025 18 December 2025: JSKN003 was granted Breakthrough Therapy Designation by the FDA for the treatment of PROC Alphamab Oncology announced that the U.S. FDA has granted Breakthrough Therapy Designation to JSKN003 for the treatment of adult patients with […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 13 December to 19 December 2025
Huadong Medicine announced that HDM2012 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for two indications: gastric cancer or gastroesophageal junction cancer and pancreatic cancer

Weekly Digest – December 2025 Weekly Digest – December 2025 15 December 2025: Huadong Medicine announced that HDM2012 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for two indications: gastric cancer or gastroesophageal junction cancer and pancreatic cancer Huadong […]

by Sandhya Ramalingam

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