Regulation

The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure

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

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

Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.

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

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.

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.

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

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 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.

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.

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.