Category Regulatory

Merck’s Calderasib Receives FDA Breakthrough Therapy Designation for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Merck’s Investigational KRAS Inhibitor Calderasib Receives FDA Breakthrough Therapy Designation for First-Line KRAS G12C-Mutated Lung Cancer Merck, known as MSD outside the United States and Canada, has announced a significant regulatory milestone for its oncology pipeline with the U.S. Food…

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IMFINZI Approved in U.S. as First Immunotherapy Combination for High-Risk NMIBC

IMFINZI® (durvalumab) Becomes First Approved Immunotherapy Combination in the U.S. for Patients with BCG-Naïve High-Risk Non-Muscle-Invasive Bladder Cancer AstraZeneca has secured a significant new regulatory milestone for its immunotherapy IMFINZI (durvalumab), with the U.S. Food and Drug Administration (FDA) approving…

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ReST Therapeutics Announces FDA Acceptance of IND Application for RST-101 in Early PTSD Treatment

ReST Therapeutics Receives FDA IND Clearance for PTSD Therapy RST-101 ReST Therapeutics announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for RST-101, its lead investigational therapy being developed for the early…

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Daiichi Sankyo Europe Highlights Patient-Focused Innovation with Broad Data Presentation at EAS Congress 2026

Daiichi Sankyo Europe Highlights Broad EAS Congress 2026 Data Presentations Supporting Patient-Centred Cardiovascular Care Daiichi Sankyo Europe has announced a major scientific presence at the upcoming European Atherosclerosis Society Congress 2026, highlighting the company’s continued commitment to advancing cardiovascular care…

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Hologic Showcases New ASCO 2026 Data on Breast Cancer Index® and Endocrine Therapy Decisions

Hologic Showcases New ASCO 2026 Data Highlighting the Role of the Breast Cancer Index® Test in Guiding Extended Endocrine Therapy Decisions Hologic and its subsidiary Biotheranostics have announced new clinical data showing how the Breast Cancer Index® (BCI™) Test is…

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SAGA Diagnostics Highlights NeoCircle Study on ctDNA Dynamics in Early Breast Cancer

SAGA Diagnostics Highlights NeoCircle Publication Showcasing Prognostic Impact of ctDNA Dynamics in Early Breast Cancer SAGA Diagnostics has announced the publication of new clinical research highlighting the potential of ultrasensitive circulating tumor DNA (ctDNA) monitoring to transform the management of…

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BeOne Medicines Showcases Oncology Leadership at ASCO and EHA 2026 with More Than 60 Abstracts

BeOne Medicines Showcases More Than 60 Abstracts at ASCO and EHA 2026 BeOne Medicines announced that it will present more than 60 scientific abstracts at two of the world’s most influential oncology and hematology conferences in 2026, reinforcing the company’s…

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Inocras Unveils ASCO 2026 Findings on Whole-Genome HRD Phenotyping to Predict PARP Inhibitor Response in Ovarian Cancer

Inocras Presents Real-World Evidence Supporting Whole-Genome HRD Profiling in Ovarian Cancer Treatment Inocras, a bioinformatics-driven precision oncology company specializing in whole-genome sequencing and advanced genomic analytics, has announced that new clinical findings evaluating whole-genome sequencing-based homologous recombination deficiency (HRD) phenotyping…

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BeOne Medicines Highlights Oncology Leadership at ASCO and EHA 2026 with More Than 60 Abstract Presentations

BeOne Medicines Showcases Expanding Oncology Pipeline With More Than 60 Presentations at ASCO and EHA 2026 BeOne Medicines Ltd. has announced a major presence at two of the world’s leading oncology conferences in 2026, highlighting the company’s rapidly expanding influence…

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ImmunityBio Shares ISPOR 2026 Survey on Bladder Preservation Preference in UK NMIBC Patients

ImmunityBio Survey Highlights Diverse Treatment Priorities Among Patients With BCG-Unresponsive NMIBC ImmunityBio has unveiled new patient survey findings that shed light on how individuals living with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) make treatment decisions following BCG therapy…

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Natera Showcases 35 ASCO Studies, Strengthening Leadership in Oncology Clinical Data

Natera Showcases Expansive Oncology Research Program at ASCO 2026, Highlighting Advances in MRD Testing and Precision Cancer Care Natera announced an extensive oncology research program for the 2026 Annual Meeting of the American Society of Clinical Oncology, underscoring the company’s…

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