North America

The United States and Canada.
Pharmaceuticals
Biologics

Canada's CDA-AMC backs conditional reimbursement for Yorvipath

Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
Palopegteriparatide gains a positive reimbursement recommendation in Canada for adults with chronic hypoparathyroidism inadequately controlled on standard therapy.
Biologics
Pharmaceuticals

Climb Bio CLYM116 Phase 1 data back every-12-week dosing in IgAN

Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
Pharmaceuticals
Biologics
Cell & Gene Therapy

Eledon files IND for islet cell transplant trial as Phase 3 nears

Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
Eledon Pharmaceuticals has submitted an IND for a registrational islet cell transplant study of tegoprubart, while reaffirming its Q4 2026 Phase 3 kidney trial start.
Pharmaceuticals
Biologics

Latigo Biotherapeutics raises $397m IPO to fund non-opioid pain pipeline

The Thousand Oaks biotech floated on Nasdaq in August 2026 and published NEJM data on its lead NaV 1.8 inhibitor onzotrigine in acute pain.
The Thousand Oaks biotech floated on Nasdaq in August 2026 and published NEJM data on its lead NaV 1.8 inhibitor onzotrigine in acute pain.
Pharmaceuticals
Bioprocessing
Biologics

WuXi TIDES maps the path for oligonucleotides beyond the liver

WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
Pharmaceuticals
Medical Devices
Diagnostics

PRF Technologies clears IND for OcuRing-K Phase II cataract trial

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
Pharmaceuticals
Genomics

Stoke and Biogen present 4-year zorevunersen data at EEC

Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Pharmaceuticals
Biologics

Tangram Therapeutics advances TGM-312 into MASH patient cohorts

The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
Biologics
Regulatory Science

Vaxcyte hires CMO and CLO as VAX-31 readout moves to October

Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
Medical Devices
Diagnostics

AiM Medical Robotics wins $2m NCI grant for MRI brain robot

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
Biologics
Pharmaceuticals

Attovia Therapeutics raises $332m IPO as itch drug shows Phase 1b signal

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
Pharmaceuticals
Regulatory Science

Inventiva completes patient visits in NATiV3 MASH Phase 3 trial

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Medical Devices

Nyxoah ACCCESS study hits safety and efficacy endpoints in CCC patients

Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA
Cell & Gene Therapy
Biologics

Opus Genetics to unveil OPGx-BEST1 Phase 1/2 data on 9 September

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
Cell & Gene Therapy
Biologics
Genomics

Scribe Therapeutics IPO raises $155m as STX-1150 enters clinic

The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Pharmaceuticals
Genomics

Ultragenyx Phase 3 Aspire trial fails in Angelman syndrome

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
Diagnostics
Medical Devices
Regulatory Science

Intelligent Bio Solutions hits 98% accuracy ahead of 510(k) filing

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
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