Disease

Diagnostics
Pharmaceuticals

Royal Osteoporosis Society urges Britons to check bone health risk

New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
Biologics
Pharmaceuticals

First Tracks' ANB033 hits goals in coeliac gluten challenge

ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
Diagnostics
Digital Health

Gates Foundation and Wellcome Leap commit $100m to cut stillbirths

The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
Medical Devices

Iridex MicroPulse TLT shows sustained IOP cuts in two-year study

An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
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.
Pharmaceuticals
Biologics

Idorsia aprocitentan shows double-digit BP cuts in obesity and CKM

Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
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.
Biologics
Regulatory Science

Claris Bio reports positive CSB-001 data in rare corneal disease

Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
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
Pharmaceuticals

InnoCare wins China IND approval for TL1A/IL-23p19 bispecific ICP-B161

InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
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.
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.
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.
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.
Cell & Gene Therapy
Genomics

Life Biosciences reports Phase 1 ER-100 data in glaucoma

First-in-human interim data show ER-100 was well-tolerated at Dose Level 1 in three open-angle glaucoma participants, with visual field signals
First-in-human interim data show ER-100 was well-tolerated at Dose Level 1 in three open-angle glaucoma participants, with visual field signals
Biologics
Pharmaceuticals

Roche vamikibart hits 52-week UME endpoints as FDA weighs BLA

Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
Pharmaceuticals
Biologics

iOnctura's roginolisib gets dual Nature Communications papers

Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
Pharmaceuticals
Biologics

Alumis files NDA plan for envudeucitinib after Phase 3 psoriasis data

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Pharmaceuticals
Medical Devices

MannKind presents Furoscix ReadyFlow PK/PD data at HFSA 2026

New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
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