North America

The United States and Canada.
Medical Devices
Diagnostics

CooperCompanies retains CooperSurgical and lifts buyback to $3bn

CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
Biologics
Pharmaceuticals

Genelux publishes SCLC case report showing 16.7-month PFS with Olvi-Vec

A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
Medical Devices
Diagnostics

Hexiris Ophthalmics to show OBi glaucoma data at five meetings

Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Pharmaceuticals
Diagnostics

Quantum BioPharma clears FDA IND for PAD2-targeting MS drug Lucid-MS

Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Biologics
Pharmaceuticals

Immutep refocuses efti on HNSCC and sarcoma after trial failure

Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
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.
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
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.
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.
Genomics
Diagnostics
Regulatory Science

NAD recommends Nucleus Genomics modify embryo screening ad claims

The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
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.
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.
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.
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Medical Devices

Axogen to acquire BioCircuit Technologies for $200m cash

Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Biologics
Medical Devices
Regulatory Science

Biora Therapeutics to start first human trial of oral biologic capsule

The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
Pharmaceuticals
Diagnostics

CervoMed neflamapimod nfvPPA biomarker data accepted at ISFTD 2026

CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
Cell & Gene Therapy
Biologics
Pharmaceuticals

IMUNON signs NCI CRADA to expand IMNN-001 into new solid tumours

IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
Digital Health
Diagnostics

Instinct Science launches Attending, an AI clinical assistant for vets

Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
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