Diagnostics
Genomics
Regulatory Science

Bionano Labs OGM test in line for Medicare coverage under proposed LCD

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics
Regulatory Science

CAMP4 Therapeutics wins MHRA nod for CMP-002 SYNGAP1 Phase 1/2 trial

CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pharming wins FDA approval for Joenja in children aged 4 to 11 with APDS

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Biotech Times Editorial Team  · 
Medical Devices

Intuitive meta-analysis backs da Vinci across 13 conditions

A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teitur Trophics reports Phase I safety and CNS exposure for TT-P34

The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
The Danish biotech said its Parkinson's peptide TT-P34 was well tolerated and crossed the blood-brain barrier, with biomarker signals supporting lysosomal pathway
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Resolution Therapeutics completes enrolment in EMERALD liver trial

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Nicox NCX 470 NDA accepted for review by China's NMPA

China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
The Biotech Times Editorial Team  · 
AgriTech
Diagnostics

Rad Source launches Sterile Insect Farms division for mosquito control

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
The Biotech Times Editorial Team  · 
Medical Devices

Health Textiles Nigeria begins PermaNet Dual net production

Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
The Biotech Times Editorial Team  · 
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