clearance

Datar Cancer Genetics Receives Landmark US FDA Clearance for CellDx-Tissue, a Comprehensive Genomic Profiling Assay for Solid Tumors Using DNA + RNA

Clearance Recognises CellDx-Tissue's Dual-Analyte DNA and RNA Workflow Across 517 Cancer-Associated Genes, with ALK, RET and ROS1 Fusion Calls on…

1 week ago

Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)

Multicenter, open-label study will evaluate the safety and preliminary efficacy of CK0802, a first-in-class, off-the-shelf Treg therapy, in patients with…

3 weeks ago

Cellenkos, Inc. Announces FDA Clearance to Initiate Phase 2 Clinical Trial of CK0801 (Allogeneic Cord Blood-Derived Tregs) for Aplastic Anemia

Phase 2 multicenter, open-label study (NCT07499102) will evaluate the safety and clinical efficacy of CK0801 Tregs in transfusion-dependent aplastic anemia.HOUSTON,…

4 weeks ago

Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil in Duchenne Muscular Dystrophy – CORRECTION

April 10, 2026 16:09 ET  | Source: Mesoblast Limited Working with Parent Project Muscular Dystrophy and the Duchenne Registry on…

1 month ago

Paingone Plus TENS Pen Featured in 2026 Consumer Report Examining FDA Clearance Status, TENS Pain Therapy Research, and Portable Pain Relief Device Verification

Tukwila, WA, March 05, 2026 (GLOBE NEWSWIRE) -- This report examines publicly available marketing statements and published research literature. Where…

3 months ago

FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX, Expanding Clinical Microbiology Capabilities

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with…

3 months ago

LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System

Ultra-fast point-of-care molecular diagnostics platform for key respiratory pathogens delivers results in under ten minutes February 16, 2026 05:00 ET…

3 months ago

Bioxytran Reports Positive Phase 2 Results Demonstrating Rapid Viral Clearance with ProLectin-MBioxytran

BOSTON, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Bioxytran, Inc. (OTCQB: BIXT) today announced positive clinical results from its recently completed…

3 months ago

Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage

SAN FRANCISCO, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for cancer, today announced…

4 months ago

Aptose Biosciences Announces Rescheduling of Special Meeting of Shareholders to Approve the Acquisition by Hanmi Pending Final Clearance from SEC

SAN DIEGO and TORONTO, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (TSX: APS; OTC:…

5 months ago