FDA– tag –
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FDA Introduces Flexible CMC Guidance for Cell and Gene Therapy Products, Ending ‘Rule of Three’ for Commercial Validation Batches
BioProcess International USA Overview The FDA published and immediately implemented Level 2 guidance, 'CMC Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application' on May 5, 2026. This la... -
Cultivated Meat Regulation Matures Globally: US Federal Approvals, ANZ Standards, and UK Guidance Set New Benchmarks
Dr. Mercola International Overview The global regulatory environment for cultivated meat is rapidly advancing, with five products completing federal review in the US, alongside new cell-cultivated food standards in Australia/New Zealand ... -
AGC Biologics Secures Landmark Multi-Hundred-Million-Dollar Deal for Yokohama Facility, Cementing Japan’s Biologics Manufacturing Leadership
AGC Biologics Japan Overview AGC Biologics has secured a multi-year, multi-hundred-million-dollar commercial manufacturing agreement for its new Yokohama facility, slated to open in 2027. This landmark deal dedicates approximately half o... -
Reusable Bioreactor Market Surges: Driven by Large-Volume Biologics Production and CDMO Capacity Expansion, Hybrid Manufacturing Emerges
Constancy Researchers USA Overview The reusable bioreactor market is experiencing substantial growth, propelled by the increasing demand for large-volume commercial biopharmaceutical production and the expansion of CDMO capacities. A not... -
Perfusion Bioreactor Market Surges Driven by Continuous Biomanufacturing and Intensified Bioprocessing; Thermo Fisher’s DynaDrive Platform Leads
Constancy Researchers USA Overview The perfusion bioreactor market is experiencing rapid growth, primarily fueled by the adoption of continuous biomanufacturing and intensified bioprocessing strategies. Thermo Fisher Scientific's HyPerfo... -
Biosphere CRO Identifies 2026 Clinical Trial Trends: AI, Wearable Biosensors Accelerate Drug Development
Biosphere CRO International Overview Biosphere CRO reports that 2026 clinical trials are being transformed by the maturation of AI, remote monitoring infrastructure, wearable biosensors, and cloud-native data platforms. These technologie... -
FDA Clears Dexcom’s Stelo Glucose Biosensor System as First OTC Continuous Glucose Monitor for Non-Insulin-Using Children Ages 2+
Weence.com USA Overview On June 12, 2026, the FDA approved Dexcom's Stelo Glucose Biosensor System as the first over-the-counter (OTC) continuous glucose monitor (CGM) for children aged 2 and older who do not use insulin. This system, wh... -
Freenome Secures FDA Approval for Blood-Based Colorectal Cancer Test, Advancing Non-Invasive Diagnostics
MedTech Dive USA Overview Freenome has received FDA approval for its blood-based test for colorectal cancer, marking a significant regulatory milestone in non-invasive cancer diagnostics. This development is a major advance in the field ... -
Will FDA’s Commitment to AI in Healthcare Waver? MedTech Dive Discusses Regulatory Trajectory for Biosensors and Diagnostics
MedTech Dive USA Overview A MedTech Dive article examines whether the U.S. FDA's commitment to artificial intelligence in healthcare, particularly for biosensors and diagnostics, will shift. This discussion reflects ongoing industry deba... -
DexCom Reports Strong Q2 2026 Results with 13% Revenue Growth, 50% Operating Income Surge
Stock Titan USA Overview DexCom announced robust Q2 2026 financial results, with revenue up 13% year-over-year, driven by increased disposable sensor volumes and an expanding customer base. The company also reported a significant 50% ris...
