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3089 News Found

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


Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor
News | May 29, 2025

Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor

MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume


Merck presents positive Phase 2 data for Enpatoran demonstrating reduction in disease activity in patients with CLE and SLE with active lupus rash
Diagnostic Center | May 22, 2025

Merck presents positive Phase 2 data for Enpatoran demonstrating reduction in disease activity in patients with CLE and SLE with active lupus rash

Enpatoran is a potential first-in-class oral therapy for CLE and SLE that is thought to selectively block the activation of Toll-like receptors (TLR)7 and TLR8


AstraZeneca, Daiichi Sankyo announce Enhertu plus pertuzumab demonstrated clinically meaningful improvement as 1st-line therapy for patients with metastatic breast cancer
News | April 22, 2025

AstraZeneca, Daiichi Sankyo announce Enhertu plus pertuzumab demonstrated clinically meaningful improvement as 1st-line therapy for patients with metastatic breast cancer

DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care


Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD
News | March 29, 2025

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD

Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


5.1 lakh TB patients notified across India
Policy | February 23, 2025

5.1 lakh TB patients notified across India

Among those identified, 2.4 lakh patients have been notified from public health institutions, while 1.1 lakh were identified through private healthcare facilities


Imfinzi perioperative regimen improved survival across muscle-invasive bladder cancer patients
News | February 15, 2025

Imfinzi perioperative regimen improved survival across muscle-invasive bladder cancer patients

Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030