North America

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  · 
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

First Choice Healthcare to go public via Westin SPAC at $650m valuation

First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
The Biotech Times Editorial Team  · 
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The Biotech Times Editorial Team  · 
Biotech

Clearmind reports clean CMND-100 safety data across dose escalation

Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
The Biotech Times Editorial Team  · 
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
The Biotech Times Editorial Team  · 

Integra LifeSciences Q2 revenue steady as SurgiMend relaunch nears

Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
The Biotech Times Editorial Team  · 
Diagnostics

CorVascular launches ASUS handheld ultrasound range at SVU 2026

CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
The Biotech Times Editorial Team  · 
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
The Biotech Times Editorial Team  · 

Beyond Air raises up to $30.1m to fund LungFit PH II launch

Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 

Aprea Therapeutics expands APR-1051 trial to ten sites ahead of Q4 data

Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Subscribe to North America