FDA– tag –
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Revolutionizing Drug Delivery: A Comprehensive Review of Polymeric Nanoparticles
Nanbiosis Spain Overview A recent review from Nanbiosis highlights polymeric nanoparticles (PNPs) as cornerstone platforms in nanomedicine, revolutionizing drug delivery, gene therapy, and medical imaging. By precisely engineering proper... -
Bridging the Data Integrity Gap in Pharmaceutical Quality Control: Ensuring Reliability for Advanced Medicinal Products
European Pharmaceutical Review EU Overview The critical importance of closing the data integrity gap in pharmaceutical quality control has been re-emphasized. For advanced medicinal products like cell and gene therapies, stringent reliab... -
FDA Approves First Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa), Offering New Option for Patients Aged 8+
Pharmacy Times USA Overview The U.S. FDA has approved the first gene therapy for Glycogen Storage Disease Type Ia (GSDIa), targeting the underlying cause of this rare metabolic disorder in patients aged 8 and older. GSDIa results from a ... -
Regenxbio’s Hunter Syndrome Gene Therapy Refiling Halted by Second FDA Clinical Hold
Fierce Biotech USA Overview Regenxbio's plan to refile its gene therapy for Hunter syndrome (MPS II) has been derailed by a clinical hold imposed by the FDA, leading the company to postpone its regulatory submission indefinitely. This ma... -
Cellistic Expands iPSC Therapy Manufacturing with New GMP Platforms for Immuno-Oncology and Regenerative Medicine
Cellistic Press Release (via PharmaTimes) Belgium Overview Cellistic has introduced three new GMP manufacturing platforms—Echo-T, Echo-Cardio, and Echo-Endothelial—significantly expanding its capabilities for iPSC-derived cell therapies.... -
Global Summits Confront Cell & Gene Therapy Scale-Up: Automation, Cost Efficiency, and Mass Production Strategies
Informa Connect International Overview Upcoming international conferences, including Advanced Therapies Europe and the CAR-TCR Summit in September 2026, are set to address the urgent need for scalable and cost-effective manufacturing in ... -
Exosome-Based Therapeutics Development Summit Convenes in Boston to Address Manufacturing, Regulatory, and Clinical Challenges
Hanson Wade Conferences USA Overview The 8th Exosome-Based Therapeutics Development Summit will be held in Boston from September 22-24, 2026, focusing on overcoming challenges in scalable manufacturing, robust analytical characterization... -
AI-Guided 3D Bioreactors Revolutionize iPSC Manufacturing: Scaling Up and Cutting Costs for Accelerated Commercialization
Wiley Analytical Science USA Overview AI-guided 3D bioreactor technology is revolutionizing iPSC manufacturing, enabling reliable, efficient, and scalable production of pluripotent stem cells (PSCs). This innovative platform facilitates ... -
Bristol Myers Squibb Terminates $380M CAR-T Manufacturing Partnership with Cellares Due to Production Failures for Breyanzi
PharmaLive USA Overview Bristol Myers Squibb (BMS) has ended its $380 million partnership with Cellares, citing Cellares' Cell Shuttle system's failure to meet commercial production requirements for BMS's CAR T-cell immunotherapy, Breyan... -
CRISPR Therapeutics Diversifies Pipeline into In Vivo Gene Editing and Off-the-Shelf CAR-T Cell Therapies, Leveraging Casgevy Commercialization Experience
Venture Atlas USA Overview CRISPR Therapeutics is strategically diversifying its pipeline, leveraging its commercialization experience with Casgevy, into in vivo gene editing programs (CTX310, CTX320, CTX340, CTX460) and allogeneic off-t...
