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

55 News Found

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US
News | July 31, 2025

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US

For patients with resectable early-stage gastric and gastroesophageal junction cancers


Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting
News | July 11, 2025

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Diagnostic Center | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia
News | June 07, 2025

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations


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


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


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