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Results For "mutations"

129 News Found

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer
Clinical Trials | June 02, 2025

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer


Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
News | June 02, 2025

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows


Pfizer’s Braftovi combination regime reduces death risk  for patients with  BRAF V600E mutant mCRC
Clinical Trials | May 31, 2025

Pfizer’s Braftovi combination regime reduces death risk for patients with BRAF V600E mutant mCRC

Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment


Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer
News | May 31, 2025

Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer

Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer
Drug Approval | April 04, 2025

AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone


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


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Drug Approval | December 21, 2024

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC

Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the