Digital Health
Diagnostics

Instinct Science launches Attending, an AI clinical assistant for vets

Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Medical Devices
Digital Health

ONWARD Medical doubles revenue as ARC-EX unit sales surge 430%

The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
Pharmaceuticals
Biologics
Medical Devices

MannKind and Rose Pharma partner on inhaled GLP-1 for weight loss

MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
Pharmaceuticals
Diagnostics

ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP

ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
Pharmaceuticals
Regulatory Science

BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Pharmaceuticals
Biologics

Caspian Therapeutics launches with $50m to target diabetes

Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
Pharmaceuticals
Regulatory Science
Biologics

Pharvaris HAE prophylaxis trial hits 83% attack rate reduction

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
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