Recent blog posts
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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Ionis Reports Promising Trial Results for Donidalorsen in Hereditary Angioedema Patients
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Ionis Reports Promising Trial Results for Donidalorsen in Hereditary Angioedema Patients
6 June 2024
Ionis shares promising outcomes from the OASIS-HAE and OASISplus trials of the experimental drug donidalorsen for hereditary angioedema patients.
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J&J Seeks EMA Approval for Subcutaneous RYBREVANT® for EGFR-Mutated Lung Cancer
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J&J Seeks EMA Approval for Subcutaneous RYBREVANT® for EGFR-Mutated Lung Cancer
6 June 2024
Johnson & Johnson has applied to the European Medicines Agency for approval of a subcutaneous version of RYBREVANT® (amivantamab) to treat patients with EGFR-mutated non-small cell lung cancer.
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Strand Therapeutics Announces Initial Patient Treated with STX-001 mRNA Therapy in Phase 1 Solid Tumor Study
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Strand Therapeutics Announces Initial Patient Treated with STX-001 mRNA Therapy in Phase 1 Solid Tumor Study
6 June 2024
Strand Therapeutics has declared that the initial patient has received a dosage in their Phase 1, first-in-human study of STX-001.
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