Regulation

Invivyd has finished enrolling 210 participants in LIBERTY, its Phase 3 head-to-head study of VYD2311 against an mRNA COVID-19 vaccine, with topline

A peer-reviewed randomised trial found the nanotechnology device reduced in-hospital opioid consumption by 26% and shortened stays by 19% after total knee arthroplasty.

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start

Ignaseclant met multiple secondary functional endpoints in 81 CMT patients, with benefits persisting seven days after the 21-day treatment ended.

NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.

Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.

Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.

The French medtech has treated its first routine patients in France, the Netherlands and Germany with its non-invasive ultrasound device for severe aortic stenosis.

Updated analyses of the CAMPX randomised trial show XWRAP plus standard care achieved complete wound closure in 31% of diabetic foot ulcer patients versus 18

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.

Pooled PATHFNDR open-label extension data show paltusotine maintained IGF-1 control and stable tumour volumes for up to 96 weeks in acromegaly patients.

The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.

Proteomic analysis of over 1,000 trial participants found lorundrostat reduced six of eleven heart failure risk biomarkers, including NT-proBNP.

New analyses from Agios's EHA 2026 plenary presentation show mitapivat reduced transfusion burden by 41% and improved pain and fatigue in sickle cell responders.

Phase 2 data presented at EHA 2026 show epcoritamab monotherapy and a combination regimen achieved strong complete response rates in first-line elderly DLBCL patients.

Insight Molecular Diagnostics says its combination model score outperforms single-metric dd-cfDNA in a peer-reviewed study of 414 kidney transplant patients.

Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.

Six-month interim data from 17 patients showed BMI reductions, fat mass loss and improved hyperphagia scores, reinforcing the case for Phase 3.

Phase 3 results for lonvo-z, published simultaneously in the NEJM, showed 62% of patients attack-free over six months with a single dose.

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.