North America

The United States and Canada.
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.
Pharmaceuticals

Avalyn Pharma raises $300m in Nasdaq IPO for fibrosis drugs

The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
Bioprocessing
Cell & Gene Therapy

Cabaletta Bio signs 10-year cell therapy supply deal with Cellares

The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
Pharmaceuticals
Regulatory Science

Quoin Pharma maps multi-indication clinical push for QRX009 rapamycin

Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Cell & Gene Therapy
Regulatory Science

Creative Medical claims 93% response rate in Ultrasome knee OA pilot

CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
Pharmaceuticals

Crescent Biopharma posts Q1 2026 results with $189m cash runway

The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
Pharmaceuticals
Regulatory Science

Cristcot to present CESSA corticosteroid data at DDW 2026

Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
Pharmaceuticals

Kestrel Therapeutics doses first patient in FALCON pan-KRAS trial

Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
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