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
The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
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
The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity
This marks the second indication for which gumokimab has gained NDA review acceptance
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases
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
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