FDA– tag –
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Cellectis’ Lasme-cel Receives FDA RMAT Designation as First Allogeneic CAR T in Pivotal Trial for R/R B-ALL, EHA Data Confirms Efficacy
Stock Titan (Cellectis SEC Filing) USA Overview Cellectis announced that its CD22-targeting allogeneic CAR T-cell therapy candidate, lasme-cel (UCART22), has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA... -
ENCell Secures US Clinical Manufacturing Contract for Ingenium’s AML-Targeting NK Cell Therapy, ‘gengleucel’
KBR South Korea Overview ENCell, a CDMO specializing in cell and gene therapies, has secured a manufacturing contract for Ingenium Therapeutics' allogeneic NK cell therapy candidate, 'gengleucel,' for U.S. clinical trials. This therapy t... -
Smartphone Digital Biomarkers Take Center Stage in Herantis Pharma’s Phase 2a Parkinson’s Trial
Biospace (Herantis Pharma press release) フィンランド Overview Herantis Pharma has finalized its HER-096 Phase 2a trial for Parkinson's disease, integrating Indivi's SynapTrack smartphone-based digital biomarker platform, following posit... -
University of Utah and UIC Develop Cuff-Less, Calibration-Free Wearable Smartwatch for Continuous Blood Pressure and Blood Flow Monitoring, Revolutionizing Cardiovascular Care with AI
University of Utah USA Overview An interdisciplinary team from the University of Utah and the University of Illinois Chicago has developed a novel wearable smartwatch capable of continuously measuring blood pressure and blood flow withou... -
Smart Contact Lenses Advance Glucose and Ocular Pressure Monitoring, with FDA-Approved Devices for Glaucoma
EyeWiki Unknown Overview Smart contact lenses are evolving beyond vision correction to non-invasively monitor glucose levels in tears and intraocular pressure. The Sensimed Triggerfish, an FDA-approved device, already tracks ocular press... -
Dexcom Reaffirms CGM Benefits for All People with Diabetes, Expands to Preventive Care with Stelo App Relaunch and Nutrisense Acquisition at ADA 2026
DexCom, Inc. USA Overview Dexcom announced favorable results from the CONNECT randomized controlled trial at ADA 2026, reaffirming CGM's benefits for non-insulin using type 2 diabetes patients. The company also launched early access to i... -
Voyager Therapeutics Receives FDA IND Clearance for VY1706, First Tau-Targeted Gene Therapy, to Begin Alzheimer’s Disease Phase 1 Trial
Cell & Gene Therapy Review USA Overview Voyager Therapeutics announced that its Investigational New Drug (IND) application for VY1706, a tau-targeted gene therapy for Alzheimer's disease, has been cleared by the FDA. VY1706 is a potent a... -
CRISPR Therapeutics Demonstrates Future Potential with Casgevy Approval, Leading Gene-Editing Market Through Pipeline Diversification
Intellectia.AI USA Overview CRISPR Therapeutics has established market leadership with the FDA approval of Casgevy, its gene-editing therapy for sickle cell disease and transfusion-dependent beta thalassemia. In 2025, 64 patients receive... -
Avaí Bio Achieves GMP Milestone for Anti-Aging Cell Therapy; Beam Therapeutics Targets Accelerated Approval for BEAM-302; Sana Partners with Mayo Clinic for Type 1 Diabetes
Newswire.ca Canada Overview Multiple biotech companies reported significant advancements: Avaí Bio completed its GMP-grade Master Cell Bank (MCB) for the α-Klotho anti-aging program, paving the way for preclinical and clinical trials. Be... -
Made Scientific and Pluristyx Announce Integrated iPSC Development & Manufacturing Partnership to Accelerate Next-Generation iPSC-Derived Cell Therapies
PR Newswire USA Overview Made Scientific, a cell therapy CDMO, and Pluristyx, an iPSC platform technology provider, announced an integrated iPSC development and manufacturing partnership. This collaboration aims to accelerate the clinica...
