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Results For "submission"

300 News Found

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


Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
News | December 08, 2023

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Clinical Trials | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease


Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs
News | October 20, 2023

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months


Kivo launches unified DMS platform ‘Kivo GO’
News | September 27, 2023

Kivo launches unified DMS platform ‘Kivo GO’

Kivo’s expanded platform brings compliant collaboration and intelligent process automation to emerging Regulatory, Clinical and Quality teams


AI to transform all processes in drug development by 2026, predicts CPHI Report
Digitisation | September 13, 2023

AI to transform all processes in drug development by 2026, predicts CPHI Report

In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs


EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema
Drug Approval | August 21, 2023

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment


Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy