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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 26 July to 01 August 2025
Chong Kun Dang’s ADC-based anticancer drug receives FDA approval for Phase 1/2 clinical trials

Weekly Digest – August 2025 Weekly Digest – August 2025 27 July 2025: Chong Kun Dang’s ADC-based anticancer drug receives FDA approval for Phase 1/2 clinical trials Chong Kun Dang secures FDA nod to launch U.S. Phase 1/2 trials for […]

by Sandhya Ramalingam

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Clinical  ·  Weekly Digest 26 July to 01 August 2025
ESMO 2025, CStone Pharmaceuticals to disclose CS5001 ADC updated study design for the first time

Weekly Digest – August 2025 Weekly Digest – August 2025 28 July 2025: ESMO 2025, CStone Pharmaceuticals to disclose CS5001 ADC updated study design for the first time The Phase 1 global, multicenter trial of CS5001 is currently ongoing in the U.S., […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 26 July to 01 August 2025
JSKN003 received the U.S FDA approval to initiate a Phase 2 clinical study in the treatment of PROC not restricted by HER2 expression

Weekly Digest – August 2025 Weekly Digest – August 2025 27 July 2025: JSKN003 received the U.S FDA approval to initiate a Phase 2 clinical study in the treatment of PROC not restricted by HER2 expression Alphamab Oncology received U.S. […]

by Sandhya Ramalingam

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Deals  ·  Weekly Digest 26 July to 01 August 2025
Owkin teams up with NeoGenomics and France Tissue Bank to build IHC-dedicated foundation model for AI-driven ADC diagnostics

Weekly Digest – August 2025 Weekly Digest – August 2025 24 July 2025: Owkin teams up with NeoGenomics and France Tissue Bank to build IHC-dedicated foundation model for AI-driven ADC diagnostics Owkin is developing an AI foundation model trained exclusively […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest 19 July to 25 July 2025
Blenrep (Belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma

Weekly Digest – July 2025 Weekly Digest – July 2025 23 July 2025: Blenrep (Belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma Health Canada approved GSK’s Blenrep in combination with Bortezomib + Dexamethasone or Pomalidomide […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest 19 July to 25 July 2025
Mirvetuximab soravtansine approved in UK to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer

Weekly Digest – July 2025 Weekly Digest – July 2025 24 July 2025: Mirvetuximab soravtansine approved in UK to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has […]

by Sandhya Ramalingam

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Approval  ·  Weekly Digest 19 July to 25 July 2025
Blenrep (Belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma

Weekly Digest – July 2025 Weekly Digest – July 2025 24 July 2025: Blenrep (Belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma Blenrep has been approved in the EU for use with BVd or BPd regimens […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 19 July to 25 July 2025
GSK announces extension of US Food and Drug Administration review period for Blenrep (Belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma

Weekly Digest – July 2025 Weekly Digest – July 2025 23 July 2025: GSK announces extension of US FDA review period for Blenrep (Belantamab mafodotin) in relapsed/refractory multiple myeloma The FDA has extended the review period for GSK’s Biologics License […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 19 July to 25 July 2025
FDA grants FTD to DB-1310 for advanced or metastatic non-squamous NSCLC

Weekly Digest – July 2025 Weekly Digest – July 2025 22 July 2025: FDA grants FTD to DB-1310 for advanced or metastatic non-squamous NSCLC DB-1310, an ADC targeting HER3, has received Fast Track Designation from the U.S. FDA for advanced […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 19 July to 25 July 2025
IND approval for LM-350 “CDH17 ADC” from the US FDA

Weekly Digest – July 2025 Weekly Digest – July 2025 24 July 2025: IND approval for LM-350 “CDH17 ADC” from the US FDA Sino Biopharmaceutical’s subsidiary, LaNova Medicines, has received the green light from the U.S. FDA to begin clinical […]

by Sandhya Ramalingam

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