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Results For "study"

1369 News Found

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Clinical Trials | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study
Clinical Trials | June 21, 2025

AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month


Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia
News | June 21, 2025

Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia

BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population


Aptar commences clinical study to accelerate FDA approval of SmartTrack
News | April 19, 2025

Aptar commences clinical study to accelerate FDA approval of SmartTrack

SmartTrack aims to reduce the need for clinical studies in generic drug product approvals


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Clinical Trials | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


Teva and Sanofi present new outcome from Phase 2b study of duvakitug
News | February 25, 2025

Teva and Sanofi present new outcome from Phase 2b study of duvakitug

Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025


Sanofi updates on extraintestinal pathogenic E. coli vaccine phase 3 clinical study
News | February 17, 2025

Sanofi updates on extraintestinal pathogenic E. coli vaccine phase 3 clinical study

No safety signals related to the vaccine candidate were identified


Equillium and Biocon announce positive data from Phase 2 study evaluating Itolizumab for ulcerative colitis
Clinical Trials | February 07, 2025

Equillium and Biocon announce positive data from Phase 2 study evaluating Itolizumab for ulcerative colitis

Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Clinical Trials | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years