North America

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

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

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

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

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

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

Shattuck Labs priced a $75 million public offering of shares and pre-funded warrants, with proceeds set to advance its DR3 antibody pipeline.

The philanthropic grant extends Part 1 of the Phase 2 VacSYn trial of ACI-7104 by two years, with final Part 1 data due in

The New York biotech raised an oversubscribed Series A led by Caffeinated Capital to scale its Raptor egg-based biomanufacturing platform.

Rafael Holdings hit last-patient-last-visit in its pivotal TransportNPC trial and expects to file an NDA for Trappsol Cyclo in the second half

Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.

Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.

Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.

FDA has authorised Alpha Tau to enrol the final seven patients in its REGAIN recurrent glioblastoma trial following encouraging interim data from the first three

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

The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.

Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.

Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.

DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.