Regulatory Science

Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle

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

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

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.

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 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

Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.

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

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

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.

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

Full results from Cohort 4 showed 88% of participants achieved physiologic glucocorticoid doses alongside sustained androgen reductions of up to 67%.

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

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

One-year open-label extension data show a 57% responder rate for canvuparatide, with Phase 3 on track to start in Q3 2026.