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Results For "design"

1661 News Found

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Tezepelumab granted Orphan Drug Designation in the US
Biotech | October 09, 2021

Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


Unum designs vaccine verification tool to track Covid-19 vaccination status
Digitisation | September 17, 2021

Unum designs vaccine verification tool to track Covid-19 vaccination status

It will also manage test result documentation for employees who are not vaccinated, sending weekly reminders and employer notification


WPO and ECR release ‘Packaging Design for Recycling Guide’
Packaging | September 15, 2021

WPO and ECR release ‘Packaging Design for Recycling Guide’

The document is a global recommendation for circular packaging design. It will be updated and adapted to changes in the collection, sorting and recycling technology, as well as to future material development


US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Drug Approval | September 12, 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


WuXi Biologics launches PatroLab digital twin platform to transform biologics manufacturing
Digitisation | January 16, 2026

WuXi Biologics launches PatroLab digital twin platform to transform biologics manufacturing

The launch of PatroLab is a pivotal milestone, marking a paradigm shift in biologics development and manufacturing