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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 10
China NMPA granted Priority Review for Zai lab’s Repotrectinib for the treatment of ROS1-positive NSCLC

Weekly Digest – 13-19 May 2023 Weekly Digest – 13-19 May 2023 May 18, 2023: Repotrectinib (IV) / ROS1-positive NSCLC / Zai lab: Received Priority Review from China NMPA Center for Drug Evaluation (CDE) of China’s NMPA granted priority review […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 10
Elevar Therapeutics filed the NDA for Rivoceranib and Camrelizumab combination in 1L HCC

Weekly Digest – 13-19 May 2023 Weekly Digest – 13-19 May 2023 May 17, 2023: Rivoceranib / Camrelizumab / Unresectable HCC / Elevar Therapeutics: Submitted a New Drug Application to FDA Elevar Therapeutics submitted NDA to the FDA based on […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 10
FDA granted FTD for ImmPACT Bio’s CAR-T therapy for R/R Aggressive B Cell Lymphoma

Weekly Digest – 13-19 May 2023 Weekly Digest – 13-19 May 2023 May 15, 2023: IMPT-314 (IV) / R/R Aggressive B Cell Lymphoma / ImmPACT Bio: Received Fast Track Designation FDA granted a Fast Track Designation for IMPT-314 a potential […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 10
China NMPA granted Breakthrough Designation for Innovent’s KRASG12Ci for previously treated CRC

Weekly Digest – 13-19 May 2023 Weekly Digest – 13-19 May 2023 May 15, 2023: IBI351 (IV) / Colorectal Cancer / Innovent Bio: Received China NMPA Breakthrough Designation China NMPA granted Breakthrough Designation (BTD) for IBI351 for the treatment of […]

by Sandhya Ramalingam

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