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Results For "New-England-Journal-of-Medicine"

53 News Found

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies
Diagnostic Center | February 28, 2024

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies

The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies


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


Enhertu approved in EU in post-ET breast cancer
Drug Approval | April 04, 2025

Enhertu approved in EU in post-ET breast cancer

Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease


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


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase 3 trial
Diagnostic Center | December 12, 2024

Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase 3 trial

First and only PARP inhibitor to improve overall survival in early breast cancer


Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC
Diagnostic Center | September 16, 2024

Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC

KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival