FDA– tag –
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FDA Draft IVD Guide Reshapes 510(k) Planning for Portable POCT and Digitally Connected Diagnostic Devices
China Med Device, LLC USA Overview The U.S. FDA released a draft guidance on August 2, 2026, titled 'In Vitro Diagnostic Devices: Classification and Regulatory Pathways Guidance.' This document clarifies the classification and 510(k) sub... -
Dexcom Achieves 13% Q2 Revenue Growth as FDA Approves OTC Glucose Biosensor Stelo for Pediatric Use
Medical Design and Outsourcing USA Overview Dexcom reported a robust 13% year-over-year revenue growth in Q2 2026, demonstrating the efficacy of its CGM technology in non-insulin-using Type 2 diabetes patients. Concurrently, the U.S. FDA... -
Dexcom Expands Beyond Diabetes Sensors to Comprehensive Health Platform with G8 Launch, Stelo Introduction, and FDA TEMPO Program Inclusion
Libre Life USA Overview Dexcom is transforming from a diabetes sensor manufacturer into a broader connected health platform, marked by the announcement of its next-gen G8 CGM, a 15-day wear extension for G7 internationally, and the launc... -
Nanotechnology Reduces Side Effects of Existing Nano-Drugs Like Doxil and Abraxane in Cancer Treatment, Enhancing Efficacy
HCG Oncology India Overview Nanotechnology significantly improves cancer treatment efficacy by resolving long-standing drug delivery challenges, enhancing both efficiency and safety. Nanoparticles, 1-100 nanometers in size, leverage the ... -
Fate Therapeutics Executives Sell Shares Post-FDA IND Approval for Next-Gen Autoimmune CAR-T Candidate FT839, Market Anticipates Basket Trial Success
TipRanks USA Overview Fate Therapeutics executives engaged in significant insider stock sales following news of the U.S. FDA's Investigational New Drug (IND) approval for FT839, its next-generation off-the-shelf CAR-T candidate for autoi... -
FDA Warns Against Unapproved Stem Cell and Exosome Therapies, Approves Products Limited to Specific Blood Disorders
The Bridge Health & Recovery USA Overview The U.S. FDA has publicly warned against clinics marketing stem cell and exosome products with false or unsubstantiated claims. Currently, FDA-approved stem cell-based products are limited, prima... -
FDA Finalizes Flexible CMC Framework for Cell and Gene Therapy Approvals, Accelerating Personalized Medicine Regulatory Pathways
BioProcess International USA Overview The U.S. FDA finalized a flexible Chemistry, Manufacturing, and Controls (CMC) framework for cell and gene therapy (CGT) product approvals, releasing a guidance document on May 5, 2026. This framewor... -
FDA Approves Tregzi, First Regulatory T-Cell (Treg) Immunotherapy for Chronic GVHD Prevention, Expands Casgevy Indication to Pediatric Patients
Cell and Gene Therapy Catapult USA Overview On June 30, 2026, the U.S. FDA approved Tregzi, the first regulatory T-cell (Treg)-based immunotherapy designed to prevent chronic graft-versus-host disease (GVHD) and improve survival. Tregzi ... -
Aspen Neuroscience’s ANPD001 Cell Therapy for Parkinson’s Disease Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation, Signaling Accelerated Development
RegMedNet USA Overview A RegMedNet report indicates that Aspen Neuroscience's ANPD001 cell therapy for Parkinson's disease has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA, based on preliminary Pha... -
IPS HEART’s iPSC-Derived Cell Therapy ISX9-CPC Receives FDA Rare Pediatric Disease Designation for Muscular Dystrophy-Associated Cardiomyopathy
StreetInsider USA Overview IPS HEART, Inc. announced that its iPSC-derived cell replacement therapy, ISX9-CPC, has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for cardiomyopathy associated with muscular dystrophi...
