FDA– tag –
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Gene and Cell Therapy See Multiple Breakthroughs: Orca Bio’s TREGZI Receives FDA Approval, Vertex/CRISPR’s CASGEVY Expands Pediatric Indication, and Carsgen’s Satri-cel Gains China Approval
YouTube (LucidQuest) USA, China Overview According to a July 9, 2026, gene and cell therapy update, Orca Bio's precision engineered cell therapy, TREGZI, received FDA approval, offering a new option for matched donor allogeneic transplan... -
FDA Regenerative Medicine Advanced Therapy (RMAT) Designations Hit Record High of 48 in 2025, Accounting for 48% of All Designations in Past Two Years
PharmaLive USA Overview According to a GlobalData report, the number of Regenerative Medicine Advanced Therapy (RMAT) designations granted by the FDA reached a record-breaking 48 in 2025, with designations in 2024 and 2025 collectively a... -
U.S. FDA RMAT Designations Surge to 165 Total, with Rocket Pharmaceuticals (5) and CRISPR Therapeutics (4) Leading the Way
BioInformant USA Overview As of July 15, 2026, the cumulative number of Regenerative Medicine Advanced Therapy (RMAT) designations publicly announced by the U.S. FDA has reached 165. Rocket Pharmaceuticals and CRISPR Therapeutics are not... -
Fate Therapeutics Secures FDA IND Clearance for FT839, a Dual iPSC-Derived CAR T-Cell Candidate, with Phase 1/2a Trial Targeting Autoimmune Diseases and Hematologic Malignancies to Commence in H2 2026
GlobeNewswire USA Overview Fate Therapeutics announced FDA IND clearance for FT839, its iPSC-derived dual CAR T-cell product candidate. FT839 is designed to simultaneously target CD19 and CD38, aiming for comprehensive treatment across a... -
FDA Clears UpDoc’s LLM Diabetes App, Grants Breakthrough Status to Aidoc’s AI Radiology Tool
MarketScale USA Overview The U.S. FDA has granted De Novo clearance for UpDoc's patient-facing large language model application for diabetes management, which provides insulin dosing instructions based on physician-authored plans. Concur... -
US Federal Regulators Approve Cultivated Chicken Sales, But Louisiana May Ban It at State Level, Creating Regional Regulatory Hurdles for Cultivated Meat Market
KTALnews.com (via Yahoo News) USA Overview U.S. federal regulators have approved the sale of cultivated chicken, marking a significant advancement for cultivated meat technology. However, state-level policies, such as those under conside... -
ARPA-H-Funded COSMIC Team Develops Closed-Loop Tear Biosensor System for Real-Time Drug Delivery and Disease Monitoring; Faces Complex FDA Path as a Combination Product
Eye Care Network - Ophthalmology Times USA Overview The ARPA-H-funded COSMIC team, led by Dr. Dipanjan Pan at Penn State University, is conducting early-stage research on a closed-loop tear biosensor system. This system aims for continuo... -
Roche Diagnostics Expands Focus on Diabetes Care, Awaiting US Approval for Accu-Chek Smartguide CGM
Indianapolis Business Journal USA Overview Swiss pharmaceutical giant Roche is continuing its expansion project within its diagnostics division in Indianapolis, with an intensified focus on diabetes care. The company is particularly awai... -
Organ Chips Advance Towards Drug Discovery Pipelines, Integrating High-Throughput, AI for Enhanced Human Disease Modeling
Drug Target Review UK Overview Organ-on-a-chip technology is evolving rapidly as a platform for modeling human diseases and evaluating drug responses, accelerating its integration into drug discovery pipelines. These microfluidic devices... -
FDA Clears Dexcom Stelo Glucose Biosensor as First Over-the-Counter CGM for Insulin-Naive Children Aged 2 and Up
U.S. Food and Drug Administration (FDA) USA Overview The U.S. FDA has granted the first over-the-counter (OTC) clearance for Dexcom's Stelo Glucose Biosensor System, expanding its use to insulin-naive children aged two and older. This la...
