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Results For "Phase-II"

537 News Found

Valneva’s next-gen Zika vaccine shows strong safety and immune response in phase I trial
Clinical Trials | November 07, 2025

Valneva’s next-gen Zika vaccine shows strong safety and immune response in phase I trial

VLA1601 is a purified and inactivated vaccine specifically designed to protect against the Zika virus


FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency
Drug Approval | November 06, 2025

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA


Bayer's finerenone approved in India for heart failure
Drug Approval | November 06, 2025

Bayer's finerenone approved in India for heart failure

The expanded approval allows Kerendia to be prescribed to heart failure patients with a LVEF of 40% or more


EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours
Clinical Trials | October 31, 2025

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1


Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions
Clinical Trials | October 31, 2025

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris


FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes
Drug Approval | October 29, 2025

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms


AstraZeneca's imfinzi cuts death risk by 22% in early gastric cancer
Clinical Trials | October 24, 2025

AstraZeneca's imfinzi cuts death risk by 22% in early gastric cancer

OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy


Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline
News | October 23, 2025

Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline

The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A


FDA approves Roche’s kidney inflammation drug
Drug Approval | October 22, 2025

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study