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Results For "clinical-development"

548 News Found

VectorBuilder Redefines Plasmid Standards with miniVec
R&D | October 08, 2025

VectorBuilder Redefines Plasmid Standards with miniVec

Conventional plasmids as a pharmaceutical material are not only suboptimal in safety and function, but exceedingly costly to produce, prohibitively


AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain
News | October 06, 2025

AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain

It represents a 30% increase in the company’s production capacity and introduces a segment dedicated to highly potent active ingredients


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial
Clinical Trials | October 01, 2025

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease
Drug Approval | September 29, 2025

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option


Pi Health to deliver clinical research services for  GSK’s Phase 2 oncology trial
News | September 26, 2025

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality


Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer
Clinical Trials | September 23, 2025

Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer

Importantly, the combination of giredestrant and everolimus was well tolerated


FDA approves Merck's Keytruda injection for cancer therapy
Drug Approval | September 21, 2025

FDA approves Merck's Keytruda injection for cancer therapy

Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute


Datavant partners with Indegene to power clinical trial recruitment
Digitisation | September 21, 2025

Datavant partners with Indegene to power clinical trial recruitment

Collaboration matches more eligible patients, including those with rare and complex diseases, to appropriate clinical trials