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Results For "CMC"

64 News Found

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Risk appetite key to innovation in pharma and biopharma
News | February 25, 2022

Risk appetite key to innovation in pharma and biopharma

Industry leaders discusses the need of innovation for the Indian drug industry at BioAsia 2022.


CARsgen Therapeutics opens new U.S. cGMP facility for CAR T production
News | February 22, 2022

CARsgen Therapeutics opens new U.S. cGMP facility for CAR T production

The RTP manufacturing facility will support the company's clinical studies and early commercial launch in North America and Europe


Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel


Novavax and Serum file EUA for Covovax in South Africa
Biotech | January 10, 2022

Novavax and Serum file EUA for Covovax in South Africa

Novavax' vaccine has received authorizations of the vaccine in over 170 countries


Novavax submits data to U.S. FDA for Covid-19 EUA
Biotech | January 03, 2022

Novavax submits data to U.S. FDA for Covid-19 EUA

Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


Novavax files emergency use listing with WHO for Covid-19 vaccine
Biotech | November 05, 2021

Novavax files emergency use listing with WHO for Covid-19 vaccine

All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO


NH TherAguix releases new batch for AGuIX
Biotech | October 29, 2021

NH TherAguix releases new batch for AGuIX

The release of this batch will secure the supply for hospitals and cancer centres that are involved in the clinical trials managed by the company