North America

The United States and Canada.
Digital Health

ApolloMD passes $1.5bn in patient medical debt relief since 2018

The physician-led practice manager has abolished over $1.5bn in patient debt via Cascade365 and non-profit Undue Medical Debt, targeting low-income patients.
The physician-led practice manager has abolished over $1.5bn in patient debt via Cascade365 and non-profit Undue Medical Debt, targeting low-income patients.
Regulatory Science

Artios Pharma adds three executives as alnodesertib nears registration

The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
Biotech

Avalo Therapeutics hits Phase 2 primary endpoint in HS trial

Abdakibart met HiSCR75 at both doses in the 253-patient LOTUS trial, with Avalo now planning a registrational Phase 3 programme in hidradenitis suppurativa.
Abdakibart met HiSCR75 at both doses in the 253-patient LOTUS trial, with Avalo now planning a registrational Phase 3 programme in hidradenitis suppurativa.
Regulatory Science
Biotech

Avalyn Pharma to present AP01 usability and IPF patient data at ATS 2026

Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Avalyn will show poster data on inhaled pirfenidone nebuliser usability and patient-centred supportive care in pulmonary fibrosis at ATS in Orlando.
Regulatory Science
Biotech

BridgeBio wins ANVISA approval for acoramidis in ATTR-CM

BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
Medical Devices
Biotech

Bioventus posts 7% Q1 revenue rise and raises 2026 earnings guidance

The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
The Durham-based medical-technology company reported Q1 net sales of $132.1m and lifted its full-year adjusted EPS and cash-flow forecasts.
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
Diagnostics
Regulatory Science

Cellectar's iopofosine I 131 shows durable WM responses at 12 months

Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
Phase 2b CLOVER WaM data show 83.6% ORR and 17.8-month median response duration, strengthening the case for accelerated FDA approval.
Regulatory Science

Cristcot names Rayna Herman to lead HCA commercial division

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Regulatory Science

Cytokinetics' aficamten hits dual Phase 3 endpoints in nHCM

ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
ACACIA-HCM met both primary endpoints — symptom burden and exercise capacity — marking the first positive Phase 3 trial in non-obstructive HCM.
Regulatory Science

Dupixent shows esophageal function gains in Phase 4 EoE trial

Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Regeneron and Sanofi's REMODEL trial found dupilumab improved esophageal distensibility and reduced structural damage in adults with EoE at 24 weeks.
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Cell & Gene Therapy

Ernexa's ERNA-101 clears tumours completely in ovarian cancer models

Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Ernexa Therapeutics reported 100% survival and complete tumour clearance for ERNA-101 combined with PD-1 blockade in preclinical ovarian cancer models.
Diagnostics

Eupraxia EoE drug shows >90% inflammation cut in Phase 1b/2a data

EP-104GI reduced EoEHSS inflammation scores by more than 90% at the highest dose tested, with fibrosis improvements sustained to 36 weeks.
EP-104GI reduced EoEHSS inflammation scores by more than 90% at the highest dose tested, with fibrosis improvements sustained to 36 weeks.
Diagnostics
Regulatory Science

EyePoint targets mid-2026 wet AMD readout as losses widen

EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
EyePoint said its DURAVYU Phase 3 wet AMD trials remain on track for topline data from mid-2026, backed by $223m in cash extending into
Diagnostics

Glucotrack CBGM hits 6.8% MARD over 240 days in ovine study

A peer-reviewed ovine study shows Glucotrack's implantable glucose monitor maintained accuracy for up to 240 days with no device-related adverse events.
A peer-reviewed ovine study shows Glucotrack's implantable glucose monitor maintained accuracy for up to 240 days with no device-related adverse events.
Regulatory Science

Immunocore posts $107m KIMMTRAK quarter with landmark five-year OS data

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
Cell & Gene Therapy

IN8bio to present GBM clinical data and TCE platform at ASCO and R&D Day

IN8bio will showcase its gamma-delta T cell engager platform and new glioblastoma clinical data across four conferences in May and June 2026.
IN8bio will showcase its gamma-delta T cell engager platform and new glioblastoma clinical data across four conferences in May and June 2026.
Regulatory Science

Integra LifeSciences returns founder-era CEO Stuart Essig to top role

Integra LifeSciences has appointed chairman Stuart Essig as president and CEO, replacing Mojdeh Poul in a permanent leadership change effective 1 May 2026.
Integra LifeSciences has appointed chairman Stuart Essig as president and CEO, replacing Mojdeh Poul in a permanent leadership change effective 1 May 2026.
Biotech

Integra LifeSciences posts Q1 revenue of $391.9m amid leadership change

The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
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