Diagnostics
Genomics

Freenome's updated SimpleScreen CRC test improves APL sensitivity

Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Medical Devices
Regulatory Science

SeaStar Medical secures ICD-10-PCS codes for SCD kidney therapy

New billing codes active from 1 October 2026 streamline hospital reimbursement for QUELIMMUNE and could accelerate adoption in paediatric AKI.
New billing codes active from 1 October 2026 streamline hospital reimbursement for QUELIMMUNE and could accelerate adoption in paediatric AKI.
Cell & Gene Therapy
Biologics

Avaí Bio and Austrianova begin San Raffaele diabetes cell trial

The joint venture Insulinova has convened its first steering committee with OSR to evaluate encapsulated beta-cell replacement for insulin-dependent diabetes.
The joint venture Insulinova has convened its first steering committee with OSR to evaluate encapsulated beta-cell replacement for insulin-dependent diabetes.
Pharmaceuticals
Regulatory Science

Milestone Pharma enrols first European patient in AFib-RVR trial

Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
Pharmaceuticals
Genomics

BridgeBio encaleret hits ADH1 endpoints as NDA earns Priority Review

Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
Biologics
Cell & Gene Therapy

NurExone advances ExoPTEN optic nerve programme to rabbit study

Positive rat-model data showing statistically significant retinal recovery will support a planned larger-animal study for NurExone's exosome candidate ExoPTEN.
Positive rat-model data showing statistically significant retinal recovery will support a planned larger-animal study for NurExone's exosome candidate ExoPTEN.
Pharmaceuticals
Regulatory Science

XORTX plans Health Canada CTA filing for gout candidate XRx-026

The Calgary biotech aims to file a Clinical Trial Application in Canada to accelerate data generation for its planned FDA NDA submission for XORLO.
The Calgary biotech aims to file a Clinical Trial Application in Canada to accelerate data generation for its planned FDA NDA submission for XORLO.
Digital Health

EliseAI partners with Nextech to embed voice AI in specialty clinics

EliseAI and Nextech are co-developing deeper API integrations to bring agentic voice AI to ophthalmology, dermatology, and orthopaedic practices.
EliseAI and Nextech are co-developing deeper API integrations to bring agentic voice AI to ophthalmology, dermatology, and orthopaedic practices.
Pharmaceuticals
Biologics

Acoramidis beats tafamidis on cardiac outcomes in real-world EHR study

A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
Diagnostics
Genomics

Cerenome wins Florida Blue coverage for CNSide CSF molecular tests

The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
Synthetic Biology
AgriTech

Fieldstone Bio joins Rio Tinto mining accelerator

The synthetic biology startup will work with Rio Tinto's geologists to commercialise biosensor-based critical-mineral measurement for exploration teams.
The synthetic biology startup will work with Rio Tinto's geologists to commercialise biosensor-based critical-mineral measurement for exploration teams.
Pharmaceuticals
Regulatory Science

Daré Bioscience presents sildenafil cream Phase 1 data at SMSNA 2026

Phase 1 data showed topical sildenafil delivered 187-fold lower peak plasma concentrations than oral dosing, supporting FSAD programme advancement.
Phase 1 data showed topical sildenafil delivered 187-fold lower peak plasma concentrations than oral dosing, supporting FSAD programme advancement.
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