North America

The United States and Canada.
Diagnostics
Digital Health
Medical Devices

Firefly Neuroscience Evoke platform to join Radial's AI clinical OS

Firefly's FDA-cleared EEG/ERP brain-function platform will be embedded into RadialOS, the AI-guided operating system used across 27 US brain medicine
Firefly's FDA-cleared EEG/ERP brain-function platform will be embedded into RadialOS, the AI-guided operating system used across 27 US brain medicine
Biologics
Pharmaceuticals

GOA Therapeutics exits stealth with $15.5m alcohol antidote

GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
Pharmaceuticals
Diagnostics

Jack Ady Cancer Centre launches Alberta's first rural cancer trial

Lethbridge's Jack Ady Cancer Centre is trialling a two-session prostate radiotherapy protocol, the first researcher-led cancer trial outside Alberta's major cities.
Lethbridge's Jack Ady Cancer Centre is trialling a two-session prostate radiotherapy protocol, the first researcher-led cancer trial outside Alberta's major cities.
Pharmaceuticals
Biologics

Rezera launches REVEAL-PAD study to map inflammation in PAD

The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
Pharmaceuticals
Regulatory Science

Syneos Health and Tufts CSDD study finds no superior CRO model

A benchmarking study across 133 trials found operating model design, not outsourcing choice, drives clinical development performance.
A benchmarking study across 133 trials found operating model design, not outsourcing choice, drives clinical development performance.
Digital Health
Diagnostics

Ultrahuman merges ring data with medical records via HealthEx

Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
Biologics
Pharmaceuticals
Diagnostics

VivoSim Labs presents NAMkind toxicity data at EUROTOX 2026

VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
Pharmaceuticals

BlossomHill raises $168m IPO and wins FDA Fast Track for BH-30643

BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
BlossomHill Therapeutics completed a $168m Nasdaq IPO and secured FDA Fast Track designation for its EGFR C797S inhibitor BH-30643 in NSCLC.
Diagnostics
Medical Devices

Conavi Medical publishes hybrid IVUS-OCT case report in CCI

A peer-reviewed case report in Catheterization and Cardiovascular Interventions shows hybrid IVUS-OCT imaging identified post-stent dissections and thrombus missed by
A peer-reviewed case report in Catheterization and Cardiovascular Interventions shows hybrid IVUS-OCT imaging identified post-stent dissections and thrombus missed by
Biologics
Pharmaceuticals

Electra Therapeutics prices upsized $350m IPO on Nasdaq

The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
Pharmaceuticals
Regulatory Science

MIRA Pharmaceuticals submits Ketamir-2 Phase 2a protocol for CIPN

MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
Pharmaceuticals
Biologics

Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Medical Devices

Treace Medical reports 5-year Lapiplasty data at AOFAS 2026

Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
Pharmaceuticals
Biologics

1ST Bio and SK Biopharma ink $314.8m Parkinson's licence for 1ST-104

The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
Biologics
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Pharmaceuticals
Regulatory Science

Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Biologics
Pharmaceuticals

Lisata Therapeutics acquires Marea and raises $225m in concurrent PIPE

Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Biologics
Pharmaceuticals

Biogen publishes Phase 3 EMPAVELI paediatric data in CJASN

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Biologics
Cell & Gene Therapy

SNIPR enrolls first Phase 2 patient in CRISPR phage trial

SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
Diagnostics
Pharmaceuticals

Sol-Gel hits LPLV milestone in Phase 3 Gorlin syndrome trial

Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
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