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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Funding

Approval  ·  Weekly Digest - 22 August to 28 August 2026
Trodelvy expanded to 1L metastatic TNBC Across PD-L1 Status in the EU

Weekly Digest – August 2026 Weekly Digest – August 2026 24 August 2026: Trodelvy expanded to 1L metastatic TNBC Across PD-L1 Status in the EU Gilead announced that the European Commission has approved Trodelvy plus Keytruda for the first-line treatment […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 22 August to 28 August 2026
Novartis’ Pluvicto receives approval in China for a new indication

Weekly Digest – August 2026 Weekly Digest – August 2026 26 August 2026: Novartis’ Pluvicto receives approval in China for a new indication Novartis announced that China’s NMPA approved a new indication for Pluvicto in combination with an androgen receptor […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 22 August to 28 August 2026
DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC

Weekly Digest – August 2026 Weekly Digest – August 2026 25 August 2026: DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC DualityBio announced that its ADAM9-targeted ADC candidate DB-1317 has been granted Fast Track Designation by the U.S. […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 22 August to 28 August 2026
SOTIO’s SOT106 granted FDA Fast Track Designation for Soft Tissue Sarcoma

Weekly Digest – August 2026 Weekly Digest – August 2026 26 August 2026: SOTIO’s SOT106 granted FDA Fast Track Designation for Soft Tissue Sarcoma SOTIO announced that the U.S. FDA has granted Fast Track Designation to SOT106, an LRRC15-targeted ADC, […]

by Sandhya Ramalingam

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Clinical  ·  Weekly Digest - 22 August to 28 August 2026
Datroway phase 3 TROPION-Urothelial04 trial initiated as adjuvant therapy for high-risk MIUC

Weekly Digest – August 2026 Weekly Digest – August 2026 26 August 2026: Datroway phase 3 TROPION-Urothelial04 trial initiated as adjuvant therapy for high-risk MIUC Daiichi Sankyo and AstraZeneca announced the initiation of the phase 3 TROPION-Urothelial04 trial, with the […]

by Sandhya Ramalingam

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Clinical  ·  Weekly Digest - 22 August to 28 August 2026
CSPC announced that SYS6010 met the pre-specified primary endpoint in phase 3 trial

Weekly Digest – August 2026 Weekly Digest – August 2026 26 August 2026: CSPC announced that SYS6010 met the pre-specified primary endpoint in phase 3 trial CSPC Pharmaceutical Group announced that its EGFR-targeted ADC SYS6010 met the pre-specified primary endpoint […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 15 August to 21 August 2026
GSK’s Blenrep combination approved in Singapore for treatment of relapsed/refractory Multiple myeloma

Weekly Digest – August 2026 Weekly Digest – August 2026 19 August 2026: GSK’s Blenrep combination approved in Singapore for treatment of relapsed/refractory Multiple myeloma GSK announced that Singapore’s Health Sciences Authority has approved Blenrep in combination with bortezomib plus […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 15 August to 21 August 2026
Akeso’s AK157D1 cleared for phase 1 trial in Solid tumors

Weekly Digest – August 2026 Weekly Digest – August 2026 21 August 2026: Akeso’s AK157D1 cleared for phase 1 trial in Solid tumors Akeso announced that its B7-H3-targeted ADC candidate AK157D1 has been cleared by China’s NMPA Center for Drug […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 15 August to 21 August 2026
CStone Pharmaceuticals receives NMPA IND approval for CS5007

Weekly Digest – August 2026 Weekly Digest – August 2026 21 August 2026: CStone Pharmaceuticals receives NMPA IND approval for CS5007 CStone Pharmaceuticals announced that China’s NMPA has approved the IND application for CS5007, an EGFR/HER3 bispecific ADC, through the […]

by Sandhya Ramalingam

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Clinical  ·  Weekly Digest - 15 August to 21 August 2026
Enhertu significantly improved PFS as 1L treatment in HER2-mutant advanced NSCLC in the phase 3 DESTINY-Lung04 trial

Weekly Digest – August 2026 Weekly Digest – August 2026 17 August 2026: Enhertu significantly improved PFS as 1L treatment in HER2-mutant advanced NSCLC in the phase 3 DESTINY-Lung04 trial AstraZeneca and Daiichi Sankyo announced that Enhertu demonstrated a statistically […]

by Sandhya Ramalingam

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