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.
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
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.
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.
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.
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
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
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.
Medical Devices
Diagnostics

NeuroOne joins Dartmouth NIH grant for neurotransmitter sensing

NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
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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