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FDA, Telix Agree on NDA Resubmission Pathway for Glioma Imaging Agent

September 10th 2025

Telix will now include an additional, confirmatory efficacy study analysis of existing data, hoping to satisfy FDA’s request for supplemental evidence and address concerns raised in a complete response letter.

Binary code and lock shape on pixellated screen | Image Credit: © JohanSwanepoel - © JohanSwanepoel - stock.adobe.com
PDA 2025: Data Governance and AI's Impact on Drug Manufacturing

September 9th 2025

Gene Therapy for Cancer Treatment Concept Cancer therapy with T-cell and pipette | Image Credit: © catalin - © catalin - stock.adobe.com
€10.7 Million Investment Accelerates Gene Writing and CAR-T Preclinical Development

September 8th 2025

We have to stick to the facts. a group of scientists working together in a lab. | Image Credit: © Courtney H/peopleimages.com - © Courtney H/peopleimages.com - stock.adobe.com
Stem Cell Community Day 2025 to Focus on Process Engineering and Scale-Up Innovation

September 8th 2025

Red and white blood cells and in the vein | Image Credit: © Tatiana Shepeleva - © Tatiana Shepeleva - stock.adobe.com
FDA Fast Track Designation for VMX-C001 Highlights Need for Improved Anticoagulant Reversal

September 4th 2025

Research into Cold Cancers Heating Up

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up; Image: catalin - stock.adobe.com
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