North America

The United States and Canada.
Digital Health

Ceribell adds two directors with device and health-system backgrounds

Nasdaq-listed Ceribell has appointed Thomas West and Sharon O'Keefe to its board as the point-of-care EEG platform reaches more than 680
Nasdaq-listed Ceribell has appointed Thomas West and Sharon O'Keefe to its board as the point-of-care EEG platform reaches more than 680
Diagnostics

Conavi Medical prices C$10m–C$15m public offering for US launch

The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
Regulatory Science

MIRA Pharmaceuticals advances MIRA-55 and SKNY-1 toward IND studies

MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling

SynCardia reveals Emperor TAH architecture at IEEE EMBC 2026

Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
Diagnostics
Digital Health

Profusa signs option to acquire diagnostics group G3 Vision Labs

The NASDAQ-listed biosensing company has secured an option to buy G3 Vision Labs, which reported around $111m in 2025 net revenues.
The NASDAQ-listed biosensing company has secured an option to buy G3 Vision Labs, which reported around $111m in 2025 net revenues.
Diagnostics

InnSight Technology wins $515k from Mellon Foundation for OcuCheck

Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Regulatory Science

Rose Hill and Control Z sign LOI for psilocybin PTSD therapy

The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
Digital Health

Glucotrack and Lōkahi Therapeutics complete reverse merger

Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
Lōkahi Therapeutics takes control of Nasdaq-listed Glucotrack, forming a public platform to acquire and advance healthcare assets via an AI-driven model.
Regulatory Science
Biologics

60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial

The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
The Washington biotech has enrolled the minimum 24 patients needed for an interim analysis, with results due by 6 October 2026.
Biologics
Regulatory Science

AB2 Bio gets $30m as Nippon Shinyaku takes U.S. Tadekinig rights

Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Nippon Shinyaku has exercised its U.S. commercialisation option for Tadekinig alfa, triggering a $30m payment and up to $600m in milestones.
Biologics

Anika Therapeutics raises 2026 guidance after record Q2 revenue

The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
Biologics

Atavistik Bio joins Cure HHT network as Harmony-HHT trial opens

Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Biologics

FDA approves Pluvicto for hormone-sensitive prostate cancer

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.

Moleculin AML trial holds 37% blinded CRc in venetoclax-failed patients

Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Interim blinded data from MIRACLE Part A show Annamycin's remission rate is unchanged even as nearly half of evaluable patients had failed prior venetoclax
Biologics

Royalty Pharma pays up to $425m for cliramitug royalty stake

Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
Regulatory Science

Tenax Therapeutics awaits Phase 3 LEVEL readout as R&D spend doubles

Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Topline data from Tenax's pivotal PH-HFpEF trial is due in August 2026, with results set for presentation at ESC Congress in Munich.
Biologics

Tiziana sees neuroinflammation fall in third MSA patient on foralumab

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
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