North America

The United States and Canada.
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.
Biotech

Kymera Therapeutics unveils KT-579 IBD preclinical data at DDW

Kymera's oral IRF5 degrader matched or outperformed JAK inhibitors and biologics in a preclinical IBD model; Phase 1 human data are due in the
Kymera's oral IRF5 degrader matched or outperformed JAK inhibitors and biologics in a preclinical IBD model; Phase 1 human data are due in the
Medical Devices

LeMaitre Vascular posts 11% Q1 sales growth on Artegraft expansion

The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
Genomics
Biotech

Madrigal licenses Arrowhead's PNPLA3 siRNA for $1bn in MASH push

Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Diagnostics
Regulatory Science

Medicus Pharma Phase 2 BCC data show dose-response at Day 57

Expanded analysis of 69 nodular BCC patients showed 200µg D-MNA achieving 55% histological clearance at Day 57, prompting FDA end-of-phase talks.
Expanded analysis of 69 nodular BCC patients showed 200µg D-MNA achieving 55% histological clearance at Day 57, prompting FDA end-of-phase talks.
Bioprocessing

Medline posts 10.7% Q1 sales growth but profits squeezed by tariffs

Medline raised its full-year organic sales guidance to 8.5–9.5% despite a 25.8% drop in net income driven by tariff costs
Medline raised its full-year organic sales guidance to 8.5–9.5% despite a 25.8% drop in net income driven by tariff costs
Digital Health

MedWell Ai reports Q3 revenues of $619k as losses narrow

The OTCQB-listed AI healthcare company more than doubled year-on-year quarterly revenues and cut its net loss by 72% as it prepares a
The OTCQB-listed AI healthcare company more than doubled year-on-year quarterly revenues and cut its net loss by 72% as it prepares a
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