FDA– tag –
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Cell and Gene Therapy Manufacturing Advances: Continuous Processing and Automated Bioreactors Tackle Scalability and Cost Challenges
News-Medical.net UK Overview Cell and gene therapy (CGT) manufacturing faces significant challenges in scalability, efficiency, and cost reduction, but new advancements in continuous processing and closed, automated bioreactor technologi... -
UniXell Biotechnology Secures FDA IND Clearance for iPSC Parkinson’s Therapy UX-DA003, Achieving Dual Breakthrough in China and U.S.
BioInformant China Overview UniXell Biotechnology has secured FDA IND clearance for UX-DA003, an iPSC-derived Parkinson's disease therapy, marking a dual breakthrough in both China and the U.S. UX-DA003 is an allogeneic iPSC-derived midb... -
PAK BioSolutions’ GMP Purification System Supports First-in-Human Trial Filing, Achieves 4x Faster Production Than Existing Facilities
FirstWord Pharma International Overview A major biopharmaceutical company has filed its first-in-human (FIH) trial, supported by PAK BioSolutions' GMP purification system. This PAK system utilizes a continuous manufacturing approach, cap... -
Biologics Outsourcing Redefined: Modality Expertise & End-to-End Integration Key for Partnerships
Bioprocess Online USA Overview Biologics manufacturing outsourcing is evolving into strategic partnerships focused on modality expertise, regulatory excellence, and end-to-end integration, moving beyond mere cost savings. To support incr... -
CDMO Signal Ranks Top FDA & GMP-Compliant Lentiviral Vector Manufacturing CDMOs
CDMO Signal Global Overview CDMO Signal has released a ranking of top Lentiviral Vector (LVV) CDMOs, crucial for ex vivo gene therapy, based on FDA inspection history, GMP certification, clinical program activity, and capacity. LVVs are ... -
Dexcom Stelo Secures First FDA OTC CGM Approval, Abbott Advances Freestyle Libre 3 Plus with 15-Day Wear & AID Compatibility
CNET USA Overview Dexcom's Stelo achieved the first FDA approval for an over-the-counter Continuous Glucose Monitor (CGM) in 2024, significantly broadening access for general consumers. Concurrently, Abbott's Freestyle Libre 3 Plus enter... -
DexCom Expands Stelo Glucose Biosensor to Non-Insulin-Using Children, Launches Redesigned App in US July 2026
WealthMagik (via Earnings Stability Report) USA Overview DexCom announced FDA approval to expand the Stelo Glucose Biosensor to non-insulin-using children aged 2 and older, aligning with the company's mission to make glucose sensing more... -
GoodRx Compares Leading CGMs: Dexcom G7 10-Day Sensor Emerges as Sole FDA-Approved Device for Children Ages 2+
GoodRx USA Overview According to a GoodRx comparison report, the Dexcom G7 10-day sensor is FDA-approved for adults and children aged 2 and older, while the Dexcom G7 15-day sensor and Eversense 365 are approved exclusively for adults ag... -
The Rise of Finger-Prick-Free Glucose Monitoring: Dexcom Stelo, Abbott Lingo, and the CGM Revolution in Metabolic Health
Mattioli 1885 イタリア Overview The U.S. FDA has approved a new generation of finger-prick-free continuous glucose monitors (CGMs) that measure interstitial fluid glucose and transmit real-time data to smartphones, largely eliminating da... -
FDA Clears Dexcom Stelo as First OTC Continuous Glucose Monitor for Non-Insulin-Using Children (Ages 2+)
HCPLive USA Overview The FDA has approved Dexcom's Stelo Glucose Biosensor System for over-the-counter (OTC) use in children aged 2 years and older who do not use insulin. This marks Stelo as the first OTC continuous glucose monitoring (...
