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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 - 04 October to 10 October 2025
ENHERTU plus pertuzumab supplemental New Drug Application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

Weekly Digest – October 2025 Weekly Digest – October 2025 07 October 2025: ENHERTU plus Pertuzumab supplemental New Drug Application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer Daiichi Sankyo has submitted a supplemental […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 04 October to 10 October 2025
Adcendo ApS announces FDA Fast Track Designation granted to ADCE-D01 for the treatment of soft tissue sarcoma

Weekly Digest – October 2025 Weekly Digest – October 2025 09 October 2025: Adcendo ApS announces FDA Fast Track Designation granted to ADCE-D01 for the treatment of soft tissue sarcoma US FDA has granted Fast Track designation to Adcendo’s ADCE-D01, […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 04 October to 10 October 2025
FDA greenlights PrimeLink Bio’s clinical trial of PLB-002

Weekly Digest – October 2025 Weekly Digest – October 2025 09 October 2025: FDA greenlights PrimeLink Bio’s clinical trial of PLB-002 The FDA has granted IND clearance for PrimeLink Bio’s first ADC candidate, PLB-002, an anti-Claudin 6 antibody-drug conjugate, enabling […]

by Sandhya Ramalingam

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