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Results For "CMC"

64 News Found

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


Lonza joins CMAC to enhance service offering for specialty, enhanced drug product and particle technologies
News | April 15, 2025

Lonza joins CMAC to enhance service offering for specialty, enhanced drug product and particle technologies

Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC) aims to accelerate the digital transformation of CMC development and manufacturing approaches


Univar Solutions becomes exclusive distributor of SD Head USA Pharmaceutical excipients in North America
Supply Chain | November 16, 2024

Univar Solutions becomes exclusive distributor of SD Head USA Pharmaceutical excipients in North America

Univar Solutions' pharmaceutical ingredients portfolio will be strengthened by the addition of a broad range of cellulose ethers and other excipient solutions


Enzene appoints new site lead of biologics manufacturing
People | September 04, 2024

Enzene appoints new site lead of biologics manufacturing

He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site


WuXi XDC partners with IntoCell to accelerate ADC discovery and development
News | January 03, 2024

WuXi XDC partners with IntoCell to accelerate ADC discovery and development

IntoCell will provide proprietary drug-linker technologies using their Ortho-Hydroxy Protected Aryl Sulfate


DxVx plans to make a license-in agreement of OVM-200
News | November 25, 2023

DxVx plans to make a license-in agreement of OVM-200

Final stage in licensing OVM-200 from Oxford Vacmedix in the UK