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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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FDA Approves Bristol Myers Squibb's Breyanzi for Relapsed/Refractory Mantle Cell Lymphoma
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4 min read
FDA Approves Bristol Myers Squibb's Breyanzi for Relapsed/Refractory Mantle Cell Lymphoma
6 June 2024
Bristol Myers Squibb has revealed that the U.S. Food and Drug Administration has given the green light to Breyanzi® (lisocabtagene maraleucel; liso-cel).
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EU Approves Bristol Myers Squibb's Opdivo® Combo for Advanced Urothelial Carcinoma
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EU Approves Bristol Myers Squibb's Opdivo® Combo for Advanced Urothelial Carcinoma
3 June 2024
The European Commission has approved Bristol Myers Squibb's Opdivo® (nivolumab) combined with cisplatin and gemcitabine for first-line therapy in adults with unresectable or metastatic urothelial carcinoma.
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Zanidatamab Receives Priority Review for HER2+ Advanced Biliary Tract Cancer
Latest Hotspot
3 min read
Zanidatamab Receives Priority Review for HER2+ Advanced Biliary Tract Cancer
3 June 2024
Jazz Pharmaceuticals plc revealed that the U.S. Food and Drug Administration (FDA) has accepted and given Priority Review status to the Biologics License Application (BLA) for zanidatamab.
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FDA Clears Full-Life Tech's 225Ac-FL-020 for Treating Metastatic Castration-Resistant Prostate Cancer
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FDA Clears Full-Life Tech's 225Ac-FL-020 for Treating Metastatic Castration-Resistant Prostate Cancer
3 June 2024
Full-Life Technologies Receives FDA IND Clearance for 225Ac-FL-020 to Treat Metastatic Castration-Resistant Prostate Cancer.
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VBI Vaccines Reports New Phase 2b Results for VBI-1901 in Recurrent Glioblastoma
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VBI Vaccines Reports New Phase 2b Results for VBI-1901 in Recurrent Glioblastoma
3 June 2024
VBI Vaccines Releases New Tumor Response Results from Ongoing Phase 2b Study of VBI-1901 in Patients with Recurrent Glioblastoma.
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CDR-Life Begins Phase 1 Trial of CDR404 for Solid Tumors at ASCO
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CDR-Life Begins Phase 1 Trial of CDR404 for Solid Tumors at ASCO
3 June 2024
CDR-Life Inc. has started enrolling participants for the Phase 1 clinical trial of CDR404, their leading candidate being developed as a targeted immunotherapy for the treatment of solid tumors.
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