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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Weekly Digest 16

Regulatory  ·  Weekly Digest 16
Antengene’s XPOVIO received regulatory approval in Hong Kong for Relapsed and/or Refractory Multiple Myeloma

Weekly Digest – 11-17 Jul 2023 Weekly Digest – 11-17 Jul 2023 17 Jul 2023: XPOVIO (selinexor) / Relapsed and/or Refractory Multiple Myeloma / Antengene: Received regulatory approval in Hong Kong HKSAR has approved an NDA for Selinexor + Dexamethasone […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 16
The FDA accepts sNDA for BeiGene’s BRUKINSA in R/R Follicular Lymphoma

Weekly Digest – 11-17 Jul 2023 Weekly Digest – 11-17 Jul 2023 12 Jul 2023: BRUKINSA (zanubrutinib) / Obinutuzumab / R/R Follicular Lymphoma / BeiGene: The US FDA accepted the sNDA for review BeiGene seeks FDA approval for BRUKINSA in […]

by Sandhya Ramalingam

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Commercial  ·  Weekly Digest 16
LianBio entered into a clinical supply agreement with AstraZeneca for BBP-398 in EGGFR Mu NSCLC

Weekly Digest – 11-17 Jul 2023 Weekly Digest – 11-17 Jul 2023 12 Jul 2023: BBP-398 / Osimertinib / EGFR mutated NSCLC / LianBio / AstraZeneca: Announced a clinical supply agreement LianBio announced a clinical supply agreement with AstraZeneca in […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 16
China’s NMPA approved Daiichi Sankyo and AstraZeneca’s ENHERTU in HER2-low metastatic Breast Cancer

Weekly Digest – 11-17 Jul 2023 Weekly Digest – 11-17 Jul 2023 12 Jul 2023: ENHERTU (trastuzumab deruxtecan) / HER2-low metastatic breast cancer / Daiichi Sankyo / AstraZeneca: Received China NMPA approval  This approval was based on the results from […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 16
Roche’s COLUMVI gets EC’s nod for relapsed/refractory diffuse large B-cell lymphoma (DLBCL)

Weekly Digest – 11-17 Jul 2023 Weekly Digest – 11-17 Jul 2023 11 Jul 2023: COLUMVI (glofitamab-gxbm) / R/R DLBCL / Roche: Approved in the EU  Based on the results from the Phase 1/2 NP30179 study, glofitamab received conditional approval […]

by Sandhya Ramalingam

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