FDA– tag –
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FDA RMAT Designations Hit Record 48 in 2025, Signaling CGT Pipeline Maturity and Market Acceleration
Pharmaceutical Technology UK Overview FDA Regenerative Medicine Advanced Therapy (RMAT) designations surged from 2024, reaching a record 48 in 2025, according to Pharmaceutical Technology analysis. This unprecedented increase reflects th... -
China Grants World’s First Solid Tumor CAR-T Approval for Satri-cel in Advanced Gastric Adenocarcinoma
Fierce Biotech USA Overview China's National Medical Products Administration (NMPA) has approved CARsgen Therapeutics' solid tumor CAR-T cell therapy, satri-cel, for HER2-negative, Claudin18.2-positive advanced gastric and gastroesophage... -
FDA RMAT Designations Reach 162 Total: Rocket Pharmaceuticals and CRISPR Therapeutics Lead
BioInformant USA Overview The FDA's publicly announced Regenerative Medicine Advanced Therapy (RMAT) designations have reached a total of 162, with approximately half of all RMAT applications being approved, according to BioInformant dat... -
FDA Approves Allogeneic Cell Therapy TREGZI for GVHD; New Advanced Cell Therapy Association Launches in Europe
RegMedNet UK Overview The FDA has approved Orca Bio's allogeneic cell therapy TREGZI (Orc-T®) for graft-versus-host disease (GVHD), based on positive Phase 3 Precision-T trial results, aiming to mitigate GVHD and reconstruct immunity. Si... -
HCA Healthcare Announces Promising Results for CRISPR Gene Therapy Exa-cel in Pediatric Sickle Cell Disease and Beta-Thalassemia Patients
HCA Healthcare USA Overview HCA Healthcare has announced findings from a New England Journal of Medicine study, sponsored by Vertex Pharmaceuticals, demonstrating that the CRISPR gene-editing therapy exa-cel shows promising results in pe... -
CRISPR’s First Clinical Evidence for HBV cccDNA Elimination, Prime Editing Advances to Inaugural Human Trial
CRISPR Medicine News USA Overview Precision Biosciences' PBGENE-HBV has demonstrated the first clinical evidence of eliminating viral cccDNA in chronic Hepatitis B patients, marking a significant milestone for CRISPR-based therapies in i... -
BioNetwork Consulting Introduces Agentic AI for Clinical Operations, Offering Expertise in Gen AI Governance and Real-World Evidence Strategy
BioNetwork Consulting USA Overview BioNetwork Consulting now offers specialized expertise in integrating Agentic AI into Clinical Operations, with a strong focus on Generative AI (Gen AI) Governance & Regulatory Compliance, and Real-... -
Data Integrity in Bioprocessing: ALCOA+ Compliance Critical for Ensuring Reliability of GMP Records
Lab Manager Global Overview In bioprocessing labs, data integrity and adherence to ALCOA+ principles are critical for meeting regulatory expectations and ensuring product safety and efficacy. All GMP records, including those from bioreac... -
UniXell Biotechnology Secures US FDA IND Clearance for Off-the-Shelf Parkinson’s Cell Therapy UX-DA003, Accelerating Dual China-US Clinical Development
BioPharma APAC USA Overview UniXell Biotechnology announced that its allogeneic iPSC-derived therapy UX-DA003 for Parkinson's disease has received Investigational New Drug (IND) approval from the US FDA. This approval enables the company... -
CNET Names Dexcom Stelo, Abbott FreeStyle Libre 3 Plus, and Eversense 365 as Top Continuous Glucose Monitors for 2026, Setting New Standards in Blood Sugar Management
CNET USA Overview CNET's 2026 review identifies Dexcom Stelo, Abbott FreeStyle Libre 3 Plus, and Eversense 365 as leading continuous glucose monitoring (CGM) devices. These systems excel in sensor life, accuracy, and FDA approval status,...
