Regulatory Science

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.

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

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

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.

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

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 confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3

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

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

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

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

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.

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

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

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.

Week 182 PaTHway Trial data show palopegteriparatide maintained biochemical normalisation and quality-of-life gains across multi-organ systems in adults with