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Results For "biomarker"

187 News Found

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer
News | January 27, 2025

Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer

BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test
News | October 21, 2024

Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test

Financing includes new funding from leading global organizations Eli Lilly and Company and EDBI


Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


Takara Bio Europe unveils new large-scale NGS profiling system and chemistries
News | September 27, 2024

Takara Bio Europe unveils new large-scale NGS profiling system and chemistries

The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run


WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines
Clinical Trials | September 23, 2024

WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results


Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial
Clinical Trials | September 10, 2024

Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial

TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population


AstraZeneca advances ambition to improve standards of care in multiple cancer types
News | September 04, 2024

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer