North America

The United States and Canada.
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
Diagnostics

NeuroSalt supplement targets neuropathy with botanical formula

A US dietary supplement brand is marketing a five-ingredient botanical capsule at peripheral neuropathy sufferers seeking alternatives to gabapentin.
A US dietary supplement brand is marketing a five-ingredient botanical capsule at peripheral neuropathy sufferers seeking alternatives to gabapentin.
Regulatory Science

Orchestra BioMed receives $15m Ligand tranche, totalling $40m

Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.
Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.
Regulatory Science

Picard Medical prices $5m offering to clear debt and fund operations

The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
Regulatory Science

Taysha reaffirms FDA BLA pathway for TSHA-102 Rett syndrome gene therapy

Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
Cell & Gene Therapy

Tempest Therapeutics reports 100% CR rate in dual-targeting CAR-T trials

TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals gains GPO coverage for TONMYA across 35m lives

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
Digital Health
Biotech

Transplants.org launches as transplant patient navigation platform

The US nonprofit has launched a centralised education and care navigation platform for organ and stem cell transplant patients, backed by 25 leading transplant centres.
The US nonprofit has launched a centralised education and care navigation platform for organ and stem cell transplant patients, backed by 25 leading transplant centres.
Regulatory Science

Trethera to present TRE-515 optic neuritis data at LABEST 2026

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
Cell & Gene Therapy

TScan Therapeutics eyes Phase 3 TCR-T launch in Q2 with $128m cash

TScan Therapeutics plans to initiate its pivotal ALLOHA-2 study of TSC-101 in haematological malignancies this quarter, backed by $128m in cash.
TScan Therapeutics plans to initiate its pivotal ALLOHA-2 study of TSC-101 in haematological malignancies this quarter, backed by $128m in cash.
Diagnostics
Regulatory Science

UroGen's ZUSDURI more than doubles revenue in Q1 2026

UroGen posted $29.2m in ZUSDURI sales in Q1 2026, up 109% quarter-on-quarter, as a permanent J Code unlocked broader reimbursement access.
UroGen posted $29.2m in ZUSDURI sales in Q1 2026, up 109% quarter-on-quarter, as a permanent J Code unlocked broader reimbursement access.
Diagnostics

Verrica Pharmaceuticals to present VP-315 abscopal BCC data at SID 2026

Phase 2 data show VP-315 reduced untreated basal cell carcinoma lesions by 67%, suggesting a systemic immune response beyond the injection site.
Phase 2 data show VP-315 reduced untreated basal cell carcinoma lesions by 67%, suggesting a systemic immune response beyond the injection site.
Diagnostics
Regulatory Science

Zentalis doses first patient in Phase 3 ASPENOVA ovarian cancer trial

Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.
Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.
Pharmaceuticals
Genomics

Annovis Bio publishes Phase 2/3 buntanetap Alzheimer's data in Nature

Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
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