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Results For "regulatory"

1140 News Found

Venus Remedies gets marketing approvals for oncology medicine from 4 key markets
News | July 05, 2023

Venus Remedies gets marketing approvals for oncology medicine from 4 key markets

With this, the number of marketing approvals for its oncology products across 75 countries has gone up to 503


Biocon Biologics expands footprint in emerging markets
News | July 05, 2023

Biocon Biologics expands footprint in emerging markets

Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries


Lonza collaborates with Vertex on cell, gene technologies manufacturing
News | June 28, 2023

Lonza collaborates with Vertex on cell, gene technologies manufacturing

Under the terms of the collaboration, Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated new facility in Portsmouth, New Hampshire (US)


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands


Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


Moderna files for FDA authorization of its Covid-19 Vaccine
Drug Approval | June 27, 2023

Moderna files for FDA authorization of its Covid-19 Vaccine

Supply readiness follows months of manufacturing to ensure timely and ample supply


Polyplastics announces commercial availability of DURACON POM PM Series for medical industry
News | June 23, 2023

Polyplastics announces commercial availability of DURACON POM PM Series for medical industry

The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.


Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals
News | June 21, 2023

Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals

This patent-pending, high-efficiency chromatography media is used for the purification of novel peptide-based pharmaceuticals in the GLP-1 agonist class including type 2 diabetes and obesity treatments


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


MoS Health addresses TB Health Technologies workshop
News | June 17, 2023

MoS Health addresses TB Health Technologies workshop

Urges Innovators to produce quality products that can be deployed at scale