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Results For "biomarker"

200 News Found

Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease
News | June 16, 2025

Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease

Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression


iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients
Clinical Trials | June 04, 2025

iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients

The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


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