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Results For "mutations"

129 News Found

Bayer and Kumquat initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors
News | October 10, 2025

Bayer and Kumquat initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

First patients enrolled in Phase I trial with KQB548, an investigational KRAS inhibitor designed to treat KRAS G12D-mutated tumors


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
Drug Approval | September 29, 2025

FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor


Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment
News | September 24, 2025

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion


FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC
Drug Approval | September 03, 2025

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations


AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease
Biotech | August 16, 2025

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025
Clinical Trials | July 09, 2025

Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025

Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment


UK MHRA approves aumolertinib to treat non-small cell lung cancer
Drug Approval | June 05, 2025

UK MHRA approves aumolertinib to treat non-small cell lung cancer

Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor