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2947 News Found

European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis
Drug Approval | February 20, 2024

European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis

VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis


Merck’s Keytruda reduced the risk of death by 38% for patients with RCC
Diagnostic Center | January 29, 2024

Merck’s Keytruda reduced the risk of death by 38% for patients with RCC

Keynote -564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC


USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Drug Approval | January 10, 2024

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy


USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
Drug Approval | November 22, 2023

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients


GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Drug Approval | November 21, 2023

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024


Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients


LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia
Diagnostic Center | October 23, 2023

LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia

LG Chem is making progress in the development of the world's first oral treatment for rare forms of obesity.