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Results For "FDA-clearance"

54 News Found

Truvian Health bags FDA clearance for CBC on TruVerus System
Drug Approval | January 28, 2026

Truvian Health bags FDA clearance for CBC on TruVerus System

TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample


Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection
Drug Approval | July 09, 2024

Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection

Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux


Roche receives FDA clearance on its digital pathology solution for diagnostic use
News | June 20, 2024

Roche receives FDA clearance on its digital pathology solution for diagnostic use

This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions


Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform
Digitisation | May 23, 2024

Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform

For use with Hamamatsu Images acquired with the NanoZoomer S360MD slide scanner


Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit
News | February 15, 2024

Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit

The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies


BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement
Digitisation | November 28, 2023

BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement

First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease


NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate
Drug Approval | April 15, 2023

NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate

Study efficacy measures will include the expression of dystrophin protein and motor function.


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.