Regulation

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.
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
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.
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
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.
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.
Medical Devices
Pharmaceuticals

Beyond Air posts record $2.3m quarter as LungFit PH adoption grows

Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
Digital Health
Diagnostics
Bioinformatics

BioNexus secures exclusive CogniAI licence for Malaysian healthcare AI

BioNexus Gene Lab will build AI document-processing applications for Malaysia's public healthcare digitisation programme under a ten-year exclusive licence.
BioNexus Gene Lab will build AI document-processing applications for Malaysia's public healthcare digitisation programme under a ten-year exclusive licence.
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
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.
Biologics
Pharmaceuticals

NovaBridge to present givastomig Phase 1b data at ESMO 2026

Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
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
Biotech

Tilray Brands posts record Q1 revenue of $257m, up 23% year-on-year

Tilray Brands reported record first-quarter net revenue of $257m, driven by beverage growth and EMEA expansion, while reaffirming its fiscal 2027 adjusted EBITDA
Tilray Brands reported record first-quarter net revenue of $257m, driven by beverage growth and EMEA expansion, while reaffirming its fiscal 2027 adjusted EBITDA
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
Pharmaceuticals
Biologics

Mineralys lorundrostat hits BP target in 46% of resistant HTN patients

New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
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