Recent blog posts
AbbVie's JAK inhibitor, Upadacitinib Extended-Release Tablet, has been approved in China for two new indications, the treatment of nr-axSpA and AS
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AbbVie's JAK inhibitor, Upadacitinib Extended-Release Tablet, has been approved in China for two new indications, the treatment of nr-axSpA and AS
1 November 2023
Recently, AbbVie announced that the National Medical Products Administration (NMPA) of China has approved two new indications for its JAK inhibitor, upadacitinib extended-release tablets.
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The FDA has granted IND approval to Biosyngen's BST02, a groundbreaking TIL therapy for liver cancer, the first of its kind globally
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The FDA has granted IND approval to Biosyngen's BST02, a groundbreaking TIL therapy for liver cancer, the first of its kind globally
1 November 2023
The US FDA has approved Biosyngen's BST02 for clinical trials. This cutting-edge TIL liver cancer therapy is a pioneer in cellular and gene therapy and is the first universal liver cancer TIL treatment to progress to the clinical stage.
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Genentech's Vabysmo gets FDA authorization for use in treating Retinal Vein Occlusion (RVO)
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Genentech's Vabysmo gets FDA authorization for use in treating Retinal Vein Occlusion (RVO)
31 October 2023
Genentech has communicated that the FDA has given approval for Vabysmo®(faricimab-svoa) to be used in treating macular edema that occurs after retinal vein occlusion.
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Tenaya Therapeutics receives FDA approval to initiate the clinical trial of TN-401 gene therapy for treating PKP2-related Arrhythmogenic Right Ventricular Cardiomyopathy
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Tenaya Therapeutics receives FDA approval to initiate the clinical trial of TN-401 gene therapy for treating PKP2-related Arrhythmogenic Right Ventricular Cardiomyopathy
31 October 2023
Tenaya Therapeutics, a clinical-phase biotech firm focusing on heart disease treatments, announced today they've received FDA approval for their IND application to begin clinical trials for TN-401.
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Mustang Bio confirms that FDA has approved the IND application for MB-109, aimed at treating recurrent Glioblastoma and High-Grade Astrocytoma
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Mustang Bio confirms that FDA has approved the IND application for MB-109, aimed at treating recurrent Glioblastoma and High-Grade Astrocytoma
31 October 2023
Mustang Bio, Inc., a biopharmaceutical firm conducting clinical trials and developing cell and gene therapies for difficult cancers and rare genetic diseases, announced FDA approval of their IND application for MB-109.
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CSPC Pharmaceutical Group's Claudin6/CD137 Dual Antibody NBL-028 has been approved for clinical trials, aimed at treating late-stage solid tumors
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CSPC Pharmaceutical Group's Claudin6/CD137 Dual Antibody NBL-028 has been approved for clinical trials, aimed at treating late-stage solid tumors
30 October 2023
Recently, CSPC Pharmaceutical announced that its independently developed bispecific antibody targeting Claudin6/CD137, NBL-028, has received approval from the National Medical Products Administration (NMPA) in China for clinical trial applications.
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Biogen's tau-targeted antisense oligonucleotide therapy shows positive clinical data in the treatment of Alzheimer's disease
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Biogen's tau-targeted antisense oligonucleotide therapy shows positive clinical data in the treatment of Alzheimer's disease
30 October 2023
Recently, Biogen announced positive results from the Phase 1b trial of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau protein for the treatment of mild Alzheimer's Disease (AD).
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Immatics TCR-T therapy IMA203 is granted RMAT designation by CBER for the treatment of multiple types of cancer
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Immatics TCR-T therapy IMA203 is granted RMAT designation by CBER for the treatment of multiple types of cancer
30 October 2023
Recently, Immatics announced that its T cell receptor T cell (TCR-T) therapy IMA203 under research has been granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA.
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Anshi Biotechnology's small molecule selective MET inhibitor, Bozitinib, has applied for marketing for a new indication, the treatment of gliomatosis cerebri
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Anshi Biotechnology's small molecule selective MET inhibitor, Bozitinib, has applied for marketing for a new indication, the treatment of gliomatosis cerebri
27 October 2023
On Oct 24, 2023, China's CDE announced that Purunao Biotechnology, a subsidiary of Anshi Biotechnology, applied to list a new indication for the Class 1 new drug Vebreltinib on their official website.
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The marketing application for Huadong Medicine's FRα ADC Mirvetuximab Soravtansine Injection has been accepted
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The marketing application for Huadong Medicine's FRα ADC Mirvetuximab Soravtansine Injection has been accepted
27 October 2023
On Oct 25, 2023, Huadong Medicine's subsidiary, Hangzhou Zhongmeihuadong Pharmaceutical, was granted a "Notice of Acceptance" by the NMPA for their marketing application for Mirvetuximab Soravtansine Injection (IMGN853, HDM2002), co-developed with ImmunoGen.
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Celltrion's Infliximab (subcutaneous formulation) receives FDA approval for the treatment of inflammatory bowel disease
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Celltrion's Infliximab (subcutaneous formulation) receives FDA approval for the treatment of inflammatory bowel disease
27 October 2023
On Oct 25, 2023, Celltrion reported US FDA approval of Zymfentra (infliximab) for continued treatment of adult ulcerative colitis (UC) and Crohn's disease (CD) after intravenous infliximab treatment.
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Yasheng Pharmaceutical's Bcl-2/Bcl-xL dual-target inhibitor, APG-1252, releases its latest Phase 1b clinical trial data for the treatment of non-small cell lung cancer
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Yasheng Pharmaceutical's Bcl-2/Bcl-xL dual-target inhibitor, APG-1252, releases its latest Phase 1b clinical trial data for the treatment of non-small cell lung cancer
26 October 2023
Yasheng Pharmaceutical presented updated clinical data for APG-1252 and Osimertinib to treat EGFR mutation lung cancer patients at the 2023 ESMO meeting on October 23, 2023.
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