North America

The United States and Canada.
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Regulatory Science

Nephros touts ultrafiltration tech as microplastic risk gains EPA focus

Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Biologics
Regulatory Science

Denali Therapeutics sells rare paediatric PRV for $195m

Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.

FocalTherics partners with MellingMedical to bring HIFU to VA system

FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
Regulatory Science

Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104

Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
Biologics

Memo Therapeutics presents full Phase II potravitug data at ATC 2026

Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Biologics
Genomics

Prime Medicine clears NZ hurdle for first in vivo Prime Editing trial

Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Regulatory Science

Teva files NDA for ecopipam in paediatric Tourette syndrome

Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
Diagnostics

Avalyn completes Phase 2b MIST enrollment for inhaled pirfenidone

Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
Biologics

Biogen to acquire RayThera for up to $1bn to bolster immunology pipeline

Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biologics

Connect Biopharma fills Phase 2 asthma study of rademikibart

The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
Biologics

Lexeo Therapeutics publishes LX2006 Phase I/II data in JAMA Cardiology

Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Biologics

Odyssey Therapeutics IPO raises $315m as OD-001 hits UC proof-of-concept

The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
Biologics
Regulatory Science

Sernova wins FDA Orphan Drug tag for autologous islet transplant

The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
Biologics
Regulatory Science

uniQure to file AMT-130 BLA for Huntington's disease in Q3 2026

The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
Biologics

Utebzi approved as first oral carbapenem for cUTIs in the US

The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
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