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European Commission Approves Biogen’s QALSODY® for Rare Genetic ALS
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European Commission Approves Biogen’s QALSODY® for Rare Genetic ALS
7 June 2024
The European Commission has approved Biogen's QALSODY® (tofersen), a pioneering treatment for a rare genetic type of ALS.
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Immunocore Unveils Phase 1 Brenetafusp (IMC-F106C) Results in Melanoma Patients at ASCO 2024
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Immunocore Unveils Phase 1 Brenetafusp (IMC-F106C) Results in Melanoma Patients at ASCO 2024
7 June 2024
Immunocore reveals new Phase 1 results for brenetafusp (IMC-F106C), a bispecific ImmTAC targeting PRAME, in melanoma patients previously treated with immune checkpoint inhibitors at ASCO 2024.
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Actym Therapeutics Reveals IND Approval for Phase 1 Trial of ACTM-838 in Solid Tumor Patients
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Actym Therapeutics Reveals IND Approval for Phase 1 Trial of ACTM-838 in Solid Tumor Patients
7 June 2024
Actym Therapeutics revealed that the U.S. FDA allowing the commencement of a Phase 1 clinical trial for its primary drug candidate, ACTM-838.
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FDA Acknowledges Astellas' Resubmitted Zolbetuximab Application, Sets New Target Date
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FDA Acknowledges Astellas' Resubmitted Zolbetuximab Application, Sets New Target Date
7 June 2024
U.W. FDA recognizes Astellas' resubmitted biologics license application for zolbetuximab and establishes a new target date.
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Gilead Shares Latest Information on the Phase 3 TROPiCS-04 Trial
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Gilead Shares Latest Information on the Phase 3 TROPiCS-04 Trial
7 June 2024
This TROPiCS-04 trial compared the effects of Trodelvy (sacituzumab govitecan-hziy; SG) against single-agent chemotherapy in individuals with metastatic urothelial carcinoma (mUC).
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NMPA Approves Ivonescimab with Chemotherapy for EGFRm NSCLC in China: HARMONi-A Trial Highlights Improved Survival
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NMPA Approves Ivonescimab with Chemotherapy for EGFRm NSCLC in China: HARMONi-A Trial Highlights Improved Survival
7 June 2024
Ivonescimab plus chemotherapy approved by NMPA for 2L+ EGFRm NSCLC in China: HARMONi-A Trial shows positive overall survival trend for the combination.
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TransCode Therapeutics Reports Promising Initial Human Trial Results for New Therapy, TTX-MC138
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TransCode Therapeutics Reports Promising Initial Human Trial Results for New Therapy, TTX-MC138
7 June 2024
TransCode Therapeutics Announces Positive Data from Initial Human Trial of New Lead Therapy Candidate, TTX-MC138.
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Biohaven Administers First Dose of New Trop-2 Targeting ADC BHV-1510 to Cancer Patient
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Biohaven Administers First Dose of New Trop-2 Targeting ADC BHV-1510 to Cancer Patient
7 June 2024
Biohaven administers initial dose of new Trop-2 targeting ADC BHV-1510 to patient with advanced or metastatic epithelial cancers.
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FDA Approves Full-Life Technologies' IND Application for 225Ac-FL-020 in Treating Metastatic Castration-Resistant Prostate Cancer
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FDA Approves Full-Life Technologies' IND Application for 225Ac-FL-020 in Treating Metastatic Castration-Resistant Prostate Cancer
7 June 2024
Full-Life Technologies Gets FDA Nod for IND Application of 225Ac-FL-020 in Treating Metastatic Castration-Resistant Prostate Cancer.
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Zanidatamab Receives Priority Review for HER2-Positive Advanced Biliary Tract Cancer
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Zanidatamab Receives Priority Review for HER2-Positive Advanced Biliary Tract Cancer
7 June 2024
Jazz Pharmaceuticals plc has reported that the Biologics License Application for zanidatamab, has been accepted and given Priority Review status by the U.S. Food and Drug Administration.
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Telix Announces Positive rPFS Results from ProstACT SELECT Trial for Prostate Cancer Therapy TLX591
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Telix Announces Positive rPFS Results from ProstACT SELECT Trial for Prostate Cancer Therapy TLX591
6 June 2024
Telix Reports Encouraging rPFS Results from TLX591 rADC Therapy Candidate ProstACT SELECT Trial for Prostate Cancer.
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U.W. FDA notes Astellas' refiled biologics license for zolbetuximab, assigns new review date
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U.W. FDA notes Astellas' refiled biologics license for zolbetuximab, assigns new review date
6 June 2024
Astellas Pharma Inc. revealed that the U.S. Food and Drug Administration has recognized their resubmission of the Biologics License Application for zolbetuximab.
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