Quality/GMPs

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Latest News

Human eye close-up in black and white. Extended pupil | Image Credit: © Annashou - stock.adobe.com
VeonGen’s Stargardt Disease Gene Therapy Gets FDA RMAT Status

August 22nd 2025

VeonGen provided the first update to its lead investigational gene therapy since announcing a company rebrand in June 2025.

PRAGUE, CZECHIA - NOVEMBER 1, 2019: Astellas logo in front of their main office for Prague. Astellas Pharma is a Japanese Pharmaceutical company spread worldwide | Image Credit: © Jerome - stock.adobe.com
Astellas and Pfizer Bladder Cancer Therapy Recommended by UK’s NICE

August 21st 2025

The front of the REGENXBIO facility in Rockville, Montgomery County, Maryland. REGENXBIO is a biotechnology company researching Adeno-Associate Virus (AAV) gene therapy | Image Credit: © MJ Kerr - stock.adobe.com
FDA Extends Review Period for REGENXBIO Hunter Syndrome Treatment

August 19th 2025

Lung cancer, 3D illustration and photo under microscope. Histopathology light micrograph of small cell lung cancer | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com
Merck and Daiichi Sankyo’s I-DXd Earns FDA Breakthrough Therapy Status in Small Cell Lung Cancer

August 19th 2025

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
FDA Grants Breakthrough Therapy Designation to Bispecific ADC for EGFR-Mutant Lung Cancer

August 18th 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Digitalization of QbD Risk Assessments; Image: photon_photo - stock.adobe.com
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