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The United States and Canada.
Cell & Gene Therapy

Cell therapy's second act: why Boston is still winning

Four years after the first wave of CAR-T IPOs, Massachusetts is quietly becoming the centre of gravity for the next generation of cell therapies — this time, for solid tumours.

When the FDA approved the first CAR-T therapy for leukaemia in 2017, the assumption across the industry was that the blood cancer playbook would translate quickly into solid tumours. It did not.

Mark Walker  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals

Profound Medical and Telix link up on PSMA-PET and MRI prostate care

The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Medical Devices

Stryker names Spencer Stiles CEO as Kevin Lobo moves to Executive Chair

Stryker's 27-year veteran Spencer Stiles will become CEO on 1 January 2027, as Kevin Lobo transitions to Executive Chair after tripling annual revenues.
Stryker's 27-year veteran Spencer Stiles will become CEO on 1 January 2027, as Kevin Lobo transitions to Executive Chair after tripling annual revenues.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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