FDA Greenlights Acepodia’s Investigational ADC Candidate ACE723 for Advanced Liver Cancer Trial

As reported on PharmaBiz, the US Food and Drug Administration (FDA) has authorized Acepodia to proceed with clinical testing of ACE723, an investigational antibody-drug conjugate (ADC) designed for patients with…

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Roche-Partnered B7-H3 ADC Meets Phase 3 Endpoint in Small Cell Lung Cancer, Shows Competitive Safety Profile

As reported on Fierce BioTech, a phase 3 study conducted by MediLink has delivered positive results for Roche-partnered antibody-drug conjugate (ADC) tambotatug pelitecan (tam-peli), also known as YL201, in patients…

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Imfinzi–Imdelltra Combination Extends Survival in First-Line Extensive-Stage Small Cell Lung Cancer

As reported on PharmaBiz, a combination of Imfinzi (durvalumab) and Imdelltra (tarlatamab) has delivered significant improvements in survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC), according to…

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FDA Authorizes Daraxonrasib for Metastatic Pancreatic Cancer After Positive Phase 3 Trial Results

As reported on World Pharma News, the U.S. Food and Drug Administration has granted approval to daraxonrasib, an oral RAS-targeting therapy, for adults with metastatic pancreatic adenocarcinoma who have previously…

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Guardant360 CDx Approved as Companion Diagnostic for AstraZeneca’s Etcamah in ESR1-Mutated Breast Cancer

As reported on Fierce BioTech, Guardant Health has secured U.S. Food and Drug Administration approval for its Guardant360 CDx liquid biopsy test as the companion diagnostic for AstraZeneca’s newly approved…

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BioNTech Ends Phase 2 Trial of Personalized mRNA Therapy in High-Risk Colorectal Cancer

As reported on Drugs, BioNTech has decided to halt development of its Phase 2 BNT122-01 study investigating autogene cevumeran (BNT122/RO7198457) in patients with resected colorectal cancer who remained ctDNA-positive after…

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Phase 3 HERIZON-GEA-01 Analysis Strengthens Survival Evidence for Zanidatamab-Based Regimens in HER2-Positive Gastroesophageal Cancer

As reported on PharmaBiz, BeOne Medicines has reported positive results from the second interim analysis of the phase 3 HERIZON-GEA-01 trial, further supporting the use of zanidatamab (Ziihera)-containing regimens as…

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EU Approves Enhertu Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

As reported on Business Wire, the European Commission has approved trastuzumab deruxtecan (Enhertu) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.…

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AstraZeneca Secures Global Rights to EGFR-Targeted Lung Cancer Therapy ZEGFROVY

As reported on Business Wire, AstraZeneca has finalized its previously announced licensing agreement with Dizal Pharmaceutical, gaining exclusive worldwide rights to develop and market ZEGFROVY (sunvozertinib), an oral, irreversible epidermal…

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