JenaValve presents LVAD and pacemaker data for Trilogy TAVR system

New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
Biologics

Nicox partner Kowa files NDA for NCX 470 glaucoma eye drop

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
Digital Health

Startup Coalition and DSIT launch Pitch in Whitehall competition

UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
Biologics
Regulatory Science

AdJane reports first human proof-of-concept for intranasal OMV vaccine

The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
Biologics

AC Immune ACI-24 shows dose-response in Phase 1b/2 Alzheimer's trial

Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
Biologics
Regulatory Science

Sanofi's Nexviazyme hits all endpoints in infantile Pompe phase 3

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Biologics

Kyowa Kirin PROSPER data show mogamulizumab eases CTCL symptoms

Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
Regulatory Science

Serenity Medical wins FDA Breakthrough Device tag for tinnitus stent

The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
Biologics

Abivax ABTECT Part 2 data back obefazimod NDA submission in UC

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
Diagnostics
Genomics
Regulatory Science

Mdxhealth GPS-ProMPT study published in European Urology Oncology

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
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