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FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Knee OA

July 18th 2025

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
FDA Approves AAVantgarde’s IND Application for Stargardt Gene Therapy

July 17th 2025

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

July 14th 2025

Syringe aimed at the center of a target. Pharmacogenetics concept, symbolizing precise drug delivery based on genetic profiles. Low poly style | Image Credit: ©Елена Бутусова -stock.adobe.com
Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

July 4th 2025

Cancer in the blood outbreak and treatment for malignant cells in a human body caused by carcinogens and genetics with a cancerous cell as an immunotherapy and leukemia or lymphoma symbol and medical | Image Credit: © freshidea - stock.adobe.com
Multiple Myeloma Treatment from Regeneron Gets FDA Accelerated Approval

July 2nd 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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