Regulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.

Trinity Biotech secured orders for over 2 million TrinScreen HIV rapid tests, supporting 2026 targets as Q1 revenue rose 43% to $10.8m.

The Dutch medtech has enrolled 15 patients and expanded its pivotal vertebral reconstruction trial across Germany and France.

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

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

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.

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

Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.

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

Olorofim matched liposomal amphotericin B on 42-day mortality in azole-refractory invasive aspergillosis, with a markedly lower adverse-event burden.

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

GraftAssure showed 99.2% agreement with a leading NGS-based assay in kidney transplant rejection monitoring, with superior analytical sensitivity at low dd-cfDNA levels.

Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.

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.

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

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