Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
The Biotech Times Editorial Team  · 
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
The Biotech Times Editorial Team  · 
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
The Biotech Times Editorial Team  · 

SynCardia reveals Emperor TAH architecture at IEEE EMBC 2026

Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
The Biotech Times Editorial Team  · 
Digital Health

Glucotrack and Lōkahi Therapeutics complete reverse merger

Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
The Biotech Times Editorial Team  · 
Biologics

Amplia Therapeutics publishes narmafotinib pancreatic cancer preprint

A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

BioNexus advances VitaGuard MRD rollout across Southeast Asia

BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
The Biotech Times Editorial Team  · 

Aprea Therapeutics expands APR-1051 trial to ten sites ahead of Q4 data

Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
The Biotech Times Editorial Team  · 
Regulatory Science

MIRA Pharmaceuticals advances MIRA-55 and SKNY-1 toward IND studies

MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
The Biotech Times Editorial Team  · 
Diagnostics

Conavi Medical prices C$10m–C$15m public offering for US launch

The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
The Biotech Times Editorial Team  · 
Regulatory Science

Rose Hill and Control Z sign LOI for psilocybin PTSD therapy

The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The Biotech Times Editorial Team  · 
Diagnostics

InnSight Technology wins $515k from Mellon Foundation for OcuCheck

Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
The Biotech Times Editorial Team  · 
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