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Results For "clinical-studies"

242 News Found

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system
News | February 18, 2026

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system

The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway


Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA
Clinical Trials | January 29, 2026

Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA

The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies


Eyestem moves closer to blindness breakthrough with phase 2 trial green light
R&D | January 29, 2026

Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity


Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator
News | January 23, 2026

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance


Camurus’ Oclaiz NDA resubmission accepted by FDA
Drug Approval | January 14, 2026

Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026


4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy
Drug Approval | January 12, 2026

4Moving Biotech bags FDA nod to launch US trial of groundbreaking osteoarthritis therapy

Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function


EpiBiologics secures $107 million in Series B to advance tissue-selective cancer therapies
Biotech | January 12, 2026

EpiBiologics secures $107 million in Series B to advance tissue-selective cancer therapies

The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue


NRG Therapeutics doses first participants in landmark ALS & Parkinson’s trial
Clinical Trials | January 11, 2026

NRG Therapeutics doses first participants in landmark ALS & Parkinson’s trial

The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases


Newron secures key European patent for schizophrenia drug Evenamide
Biopharma | January 09, 2026

Newron secures key European patent for schizophrenia drug Evenamide

This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately