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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

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Regulatory  ·  Weekly Digest - 01 August to 07 August 2026
TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer

Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer Sino Biopharmaceutical’s next-generation HER2 bispecific ADC TQB2102 has received its third Breakthrough […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 01 August to 07 August 2026
U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas

Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan has received […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 25 July to 31 July 2026
AstraZeneca receives CDSCO approval for Enhertu followed by THP for adults with HER2-positive stage II or III early Breast cancer

Weekly Digest – July 2026 Weekly Digest – July 2026 28 July 2026: AstraZeneca receives CDSCO approval for Enhertu followed by THP for adults with HER2-positive stage II or III early Breast cancer AstraZeneca Pharma India announced that the Central […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 25 July to 31 July 2026
AbbVie announces availability of ELAHERE in Singapore for the treatment of platinum-resistant Ovarian cancer

Weekly Digest – July 2026 Weekly Digest – July 2026 29 July 2026: AbbVie announces availability of ELAHERE in Singapore for the treatment of platinum-resistant Ovarian cancer AbbVie announced the availability of ELAHERE, the first folate receptor alpha-targeted antibody-drug conjugate, […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 25 July to 31 July 2026
ImmunityBio receives UAE Marketing Authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and mNSCLC

Weekly Digest – July 2026 Weekly Digest – July 2026 29 July 2026: ImmunityBio receives UAE Marketing Authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and mNSCLC ImmunityBio announced that the United Arab Emirates has granted marketing authorization […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 25 July to 31 July 2026
DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer

Weekly Digest – July 2026 Weekly Digest – July 2026 28 July 2026: DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer DualityBio and BioNTech announced that China’s NMPA has granted Breakthrough Therapy Designation […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 25 July to 31 July 2026
Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC

Weekly Digest – July 2026 Weekly Digest – July 2026 24 July 2026: Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC Gilead announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 25 July to 31 July 2026
EU CHMP recommends Enhertu plus Pertuzumab for 1L HER2 metastatic Breast cancer

Weekly Digest – July 2026 Weekly Digest – July 2026 24 July 2026: EU CHMP recommends Enhertu plus Pertuzumab for 1L HER2 metastatic Breast cancer AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency’s Committee for Medicinal Products for […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest - 18 July to 24 July 2026
Biokin Pharma announces approval of Iza-bren in China for the treatment of recurrent/metastatic ESCC

Weekly Digest – July 2026 Weekly Digest – July 2026 17 July 2026: Biokin Pharma announces approval of Iza-bren in China for the treatment of recurrent/metastatic ESCC Biokin Pharma announced that China’s NMPA has approved Iza-bren for the treatment of […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 18 July to 24 July 2026
NMPA accepts New Drug Application for Trastuzumab Envedotin injection

Weekly Digest – July 2026 Weekly Digest – July 2026 17 July 2026: NMPA accepts New Drug Application for Trastuzumab Envedotin injection CSPC Pharmaceutical Group announced that China’s NMPA has accepted the new drug application for Trastuzumab envedotin injection, a […]

by Sandhya Ramalingam

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