Regulation

The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.

The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.

FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.

A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency

Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.

Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.

A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.

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

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

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.

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

Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod

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

Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg