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• Instructions for Use of Human IFN-γ ELISA Detection Kit-IF002
• NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration” In order to improve the efficiency of drug review and approval, the National Medical Products Administration has decided to implement electronic submission of drug registration application materials. ... More+
• Industry Insight | FDA Issues Strongest Safety Warning for Sarepta’s Gene Therapy Elevidys After Two Fatal Liver Injury Cases The U.S. Food and Drug Administration (FDA) has added a boxed warning—its most serious level of safety alert—to Sarepta Therapeutics’ gene therapy Elevidys, following the deaths of two Duchenne mus... More+
• Instructions for Use of Human Residual DNA Detection Kit (qPCR)
• Industry Insight | Cellex Symposium 2025 Highlights the Next Phase of Cell and Gene Therapy Industry Development Frankfurt, Germany · November 2025 — On November 6, 2025, the Cellex Symposium 2025 was successfully held in Frankfurt, Germany, bringing together over 100 leading scientists, industry executives, r... More+
• Instructions for Use of Human Residual DNA Fragment Analysis Detection Kit (qPCR)
• Industry Insight | Avantor Unveils Next-Generation Sterile Sampling Platform to Strengthen Quality Control in CGT Manufacturing November 2025 — As the cell and gene therapy (CGT) landscape continues to expand, the need for robust aseptic monitoring and contamination control is growing rapidly. According to a recent industry r... More+
• Instructions for Use of Human Residual Total RNA Detection Kit (RT-PCR)
• Industry Insight | FDA Approves Novartis Gene Therapy Itvisma for Expanded SMA Patient Population Washington, Nov 24, 2025 — The U.S. Food and Drug Administration (FDA) has approved Itvisma, a gene therapy developed by Novartis, for a broader group of patients with spinal muscular atrophy (SMA), ... More+
• Instructions for Use of Human TNF-α ELISA Detection Kit
• Industry Insight | Oncolytic Virus CDMO Market Enters Rapid Growth Phase, Expected to Surpass USD 1.7 Billion by 2035 A newly released market report on November 26, 2025 indicates that the global oncolytic virus CDMO services market is entering a phase of accelerated growth. According to the report, the market is pro... More+
• Instructions for Use of Inorganic Pyrophosphatase ELISA Detection Kit
• Industry Insight | Genentech to Present 46 Hematology Abstracts at ASH 2025, Including New AAV Gene Therapy and Oncology Data South San Francisco, CA — November 3, 2025 — Biotech leader Genentech announced that it will present 46 abstracts, including 12 oral presentations, from its hematology portfolio at the upcoming ASH ... More+
• Instructions for Use of Kanamycin ELISA Detection Kit
• Industry Insight | Regeneron and Tessera Therapeutics Partner to Develop in-Vivo Gene Editing Therapy TSRA-196 for Alpha-1 Antitrypsin Deficiency December 1, 2025 — Regeneron Pharmaceuticals announced today a global collaboration with Tessera Therapeutics to develop and commercialize Tessera’s investigational in-vivo gene editing therapy TSRA... More+